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Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years (2011)

Chapter: Appendix A: History of Medical-Device Legislation and Regulation in the United States

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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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A

History of Medical-Device Legislation and Regulation in the United States

The committee was charged to review the 510(k) clearance process and to evaluate whether it protects patients optimally and promotes innovation in support of the public health. The Food and Drug Administration (FDA) strives to find an appropriate balance between promoting and protecting the public health.1 To aid in understanding the current 510(k) system and how it evolved to its present state, this appendix outlines pertinent elements in the history of device regulation as they are related to Class II devices generally and to the 510(k) clearance process in particular.

The 510(k) system is a type of gatekeeping for managing the transfer of new technology from the laboratory to the bedside. Entering the commercial market is a single point in the life cycle of a product. The need for and rigor of premarket review are directly affected by the availability of other tools to protect patients after marketing commences. Effective postmarketing2 controls can reduce the burdens of premarket review and accelerate its speed. Thus, this appendix will examine device regulation beyond the 510(k) process itself.

Of particular relevance is the safety surveillance system by which the FDA can identify and act on risks that emerge after a device enters the market. A robust and effective system might provide metrics for assessing

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1Federal Food, Drug, and Cosmetic Act, § 1003(b) (the most current version will hereinafter be referred to as FFDCA), 21 USC § 393(b) (2006).

2The appendix will use the word postmarketing to refer to the situation after a product enters commercial distribution. The FFDCA uses postmarket specifically to describe surveillance studies that FDA can order under Section 522. 21 USC § 360l (2006). To avoid confusion, postmarket will be used only with reference to that provision of the law.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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the nature and extent of harm that is associated with products cleared or approved by the FDA and therefore indirectly reflecting on the quality of the FDA review processes. In contrast, if safety surveillance is weak and of limited scope, that injuries are not identified can yield little confidence in the review process—absence of evidence of harm is not evidence of the absence of harm. Therefore, this appendix will review the history of adverse-event monitoring of medical devices.

Consideration of the 510(k) clearance process largely involves Class II devices. Since 1997, most Class I devices have been exempted from 510(k) review. Most Class III devices are subject to FDA review through the premarket approval (PMA) process, not the 510(k) pathway, although 25 types of Class III devices are still eligible to enter the market by the 510(k) clearance process. As recommended in Chapter 7, the committee urges the FDA to cease reliance on the 510(k) process for Class III devices as soon as possible. Once that step is completed, the 510(k) process will apply only to Class II devices—although a few are exempt from 510(k) requirements—and some Class I devices.

In considering the gatekeeping function related to the introduction of new medical products to the market, the Federal Food, Drug, and Cosmetic Act (FFDCA) has adopted a variety of approaches: no government preclearance review whatsoever, a limited preclearance review, or extensive government review. For most drug products, Congress chose detailed review and affirmative approval by the FDA before commercialization, which has led to long and expensive processes of drug development. For medical devices, however, Congress has adopted all three approaches: exemption from any premarket review by the FDA before marketing of a product; limited premarket review through a notification of intent to market, commonly called the 510(k) submission; and thorough review and affirmative approval before launching of a product (through the PMA).

After entering the market, products continue to be subject to a variety of legal requirements and prohibitions, which are enforced primarily by the FDA. Congress has given the FDA diverse powers in a patchwork fashion, usually in response to demonstrated or alleged deficiencies in current systems.3 In medical-device terminology, the requirements are called general and special controls and apply to devices according to the degree of potential

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3The laws governing medical devices have evolved separately from those applicable to drugs even though many of the authorities appropriate for one system might seem equally appropriate for the other. The nonparallel development reflects the fact that Congress often approached new issues that emerged in one field of medical products without considering whether the issues might also exist in the other. Thus, for example, with respect to medical devices Congress has given the FDA authority to order the recall of products that violate the law, to require notification of voluntary product removals, and to impose civil money penalties for violations. The FDA has none of those authorities over drugs to the same degree. Conversely, the agency has much more extensive authority over labeling, advertising, and marketing of prescription

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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risk presented but generally without regard to the extent of review before market entry. As with premarket review, postmarketing protections of health can affect innovation, depending on the rigidity and zeal with which the regulation with which regulations are enforced.

The history of federal regulation of medical devices reflects several important forces.

First, the FDA has legal constraints on its discretion in exercising its powers. To guarantee that the will of Congress would not be subverted by the executive branch, Congress set forth detailed instructions on how the FDA should carry out the law. The original Medical Device Amendments of 1976 more than doubled the length of the FFDCA as it stood at that time. Later amendments added far more text than they removed. Congressional micromanagement can be found in many parts of the current law.

To ensure presidential control over executive branch activities, the FDA has been required to submit proposed major regulations and other policies to the Office of the Secretary of Health and Human Services and to the White House Office of Management and Budget (OMB) for review and approval before publication, and there are procedural requirements for public participation to safeguard interests of patients, manufacturers, and others. Federal courts review the FDA’s interpretations of law, its regulations, and its actions. Judicial rulings can profoundly influence implementation of the medical-device statute.

Second, the FDA does not operate in a political vacuum but is subject to scrutiny as it carries out its mandates. Regulatory policies and philosophies change from one president to the next. Congressional committees that have jurisdiction over the FDA can attempt to drive the agency toward policies and actions that they prefer through oversight hearings, committee investigations, and reviews by the General Accounting Office (GAO, now the Government Accountability Office), formerly by the Office of Technology Assessment (no longer in existence), and by the Department of Health and Human Services inspector general.

Third, the modern history of the FDA shows a disparity between congressional mandates, under the various legislative enactments, and congressional appropriations of persistently insufficient resources (FDA Science Board, 2007, 9-10). The appropriation process is subject to its own set of pressures, such as tax and fiscal policy, competing demands for scarce federal revenues, and changing agendas in Congress and the executive branch. Thus, funding for the agency often bears little relation to the mandates and missions assigned by Congress. The most elegant and detailed schemes envisioned when a statute is written can become unworkable when resources

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drugs than of prescription Class II devices. The disjointed evolution of two regulatory schemes governing medical technologies can lead to public misunderstanding and confusion over the FDA’s powers and responsibilities.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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are inadequate. Necessary improvisation and tough choices at the FDA between competing priorities can move the regulatory regime in unforeseen directions.

The last force affecting the history of medical-device regulation is the inherent difficulty of resolving some core issues, which can cause them to arise again and again as different solutions prove unsatisfactory. That those issues have recurred throughout the 35 years since the medical-device statute’s enactment in 1976 demonstrates how difficult they are to resolve. Those issues include

•    Whether the 510(k) mechanism as originally enacted in 1976 or even as modified in 1990 or 1997 can even theoretically provide determinations about the safety and effectiveness of each product reviewed. Simply stated, must a finding that a new device is substantially equivalent to another lawfully marketed product (the predicate device) necessarily be a determination that the new device is safe and effective?

•    Whether the FDA can reasonably ensure the quality and consistency of 510(k) clearance decisions. Manufacturers desire predictability of the regulatory process to manage what they maintain is the inherent uncertainty and risk in innovation. Moreover, because the FFDCA requires the FDA to accept any marketed device as a predicate, flawed 510(k) decisions become embedded and must be perpetuated.

•    Whether the FDA has appropriately used its authority to establish performance standards or special controls over Class II devices. What does it mean for public health if the “reasonable assurance of the safety and effectiveness” of a Class II device cannot, by definition, be ensured by general controls alone but the agency does not impose any additional controls? Is the adoption of special controls mandatory or discretionary?

•    Whether the procedural requirements imposed by law properly balance the interests of private parties with the need for efficient and effective government actions. The preliminary recommendations of the Center for Devices and Radiological Health (CDRH) 510(k) Working Group asserted that “CDRH’s postmarket tools, while valuable, have important limitations” (FDA, 2010, p. 4). When powers given to the FDA are so encumbered by “due process” demands that they become unworkable and are not used, no one is served.

•    Whether lack of safety or effectiveness of marketed products can be promptly identified and addressed. Ultimately, the regulatory scheme to safeguard public health can be considered reliable only if society can be confident that consumers are being protected. The most important element in gaining that knowledge is surveillance of adverse

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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     medical experiences. Without a robust surveillance network to detect injuries and product ineffectiveness, there is no basis for judging the system. The absence of data on a problem does not demonstrate that a problem does not exist.

•    Whether the appropriate balance has been achieved between premarket clearance (the gatekeeping function) and postmarketing controls. Premarket clearance may add little value to protecting the public (while inhibiting innovation); in 1997, Congress eliminated 510(k) notification requirements for most Class I devices. But the preliminary recommendations of the CDRH 510(k) Working Group stated that “CDRH’s postmarket tools, while valuable, have important limitations and are not sufficient to serve as a substitute for a high-quality premarket review” (FDA, 2010, p. 4). The Working Group seems to have concluded that inadequate or ineffective postmarketing controls justify increased rigor in the preclearance process to protect consumers.

This appendix seeks to provide a chronologic inventory of medical-device legislation and external studies of its implementation. It is regrettably sprawling, shifting back and forth over seemingly disparate events and describing laws as originally enacted, even though they have been superseded by amendments. Readers are encouraged to keep in mind the six issues just identified so that they can understand the relevance of the materials presented here and to accept our apologies for the somewhat disjointed structure adopted. Although the FDA has undertaken many internal reviews and efforts to improve the process, this appendix draws most of its information from congressional materials. The focus here is on what Congress has perceived and has done concerning the goals and implementation of the FDA’s regulation of medical devices.

DEVICE REGULATION UNDER THE 1938 FEDERAL FOOD, DRUG, AND COSMETIC ACT

The Pure Food and Drug Act of 1906 did not cover medical devices. As Congress approached overhaul of the statute in the 1930s, it added that class of product to FDA jurisdiction. For all intents and purposes, however, government authority and industry legal requirements in the draft legislation were identical for both drugs and devices. Until the brink of enactment, the bills imposed no premarket review of either but subjected them to prohibitions against being “adulterated” or “misbranded.” Those terms were legal words of art and covered a variety of specific mandates or prohibitions. For example, a drug or device would be “adulterated” if it had been prepared under insanitary conditions whereby the product may have been rendered

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

injurious to health. A medical product would be “misbranded” if its label failed to identify the name and address of the manufacturer or distributor.4

The draft statute further provided that once the FDA discovered a violation of the requirements, it could seize the noncompliant product, seek an injunction against its manufacturer or distributor to prevent future violations, or recommend to the Department of Justice criminal prosecution of the persons responsible.5 Those three options were the only enforcement tools in the bill.

Final legislative action was precipitated by the elixir sulfanilamide disaster, which involved a product that put an effective drug (sulfa) into solution with a toxic solvent (diethylene glycol) that caused upward of 100 deaths in the winter of 1937–1938 (Carpenter, 2010, pp. 85–108). In response, Congress added a distinct provision applicable only to “new drugs”: premarket review of a new drug application (NDA) for safety. The manufacturer was not required to obtain FDA approval but only to provide the agency 60 days in which to make a safety assessment. If the government failed to find any safety issues within the 60-day window, the drug could enter the market.6

In that form, the FFDCA became law in 1938.

Over the next several decades, the FDA directed much of its enforcement efforts to devices, using the adulteration and misbranding provisions of the FFDCA to deal with grossly hazardous or fraudulent products. By the early 1960s, however, the agency’s attention was drawn to new technologies that were being introduced without premarket clinical testing, quality control, or patient consent.7 In 1962, Congress amended the new drug provisions of the FFDCA to require affirmative FDA approval of an NDA before marketing could begin and to require that a new drug be shown to be effective as well as safe.8

The broadened premarket authority for “new drugs” encouraged the FDA to consider applying these powers to medical devices. The opportunity to do so was supplied by the overlap in the definitions of drug and device in the original 1938 Act. As written, the terms had similar scope and were differentiated only by a drug’s being an “article” whereas a device was an “instrument, apparatus, … [or] contrivance” that was either recognized in an official compendium, such as the US Pharmacopeia; was “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”;

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4FFDCA, Pub. L. No. 75-717, §§ 501-02, 52 Stat. 1040, 1049-50 (1938).

5FFDCA §§ 301-04, 52 Stat. at 1042-45.

6FFDCA § 505, 52 Stat. at 1052-53.

7H.R. Rep. No. 94-853, at 7-8 (1976) (House Report on the Medical Device Amendments of 1976).

8Drug Amendments of 1962, Pub. L. No. 87-781 (codified as amended at 21 USC § 355(b)(1)(a)(A)).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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or was “intended to affect the structure or any function of the body.”9 In two important legal cases, the FDA persuaded federal courts that it had statutory authority to declare that products that were generally thought of as medical devices were drugs and new drugs requiring agency approval of an NDA before marketing. One product consisted of a disposable applicator, a nylon ligature loop, and a nylon locking disk used to tie off severed blood vessels during surgery; the disk and at least some of the nylon thread remained in the patient’s body.10 The other product was an antibiotic-sensitivity disk.11 Ultimately, the FDA classified a number of products as drugs before the Medical Device Amendments were enacted, including contact lenses, injectable silicone, pregnancy-test kits, and bone cement (Hutt et al., 2007, p. 977). Only devices classified as drugs were subject to any premarket review by the FDA before 1976.

DEVELOPMENT AND ENACTMENT OF THE MEDICAL DEVICE AMENDMENTS OF 1976

Presidents Kennedy, Johnson, and Nixon all recognized “the need for more comprehensive authority to regulate medical devices.”12 At the direction of the secretary of the Department of Health, Education, and Welfare (now the Department of Health and Human Services), Theodore Cooper, director of the National Heart and Lung Institute (now the National Heart, Lung, and Blood Institute) chaired a study group to consider how to approach new legislation; the group issued its report in September 1970. Among its recommendations were better differentiation of devices and drugs in federal law with the adoption of a new and distinct regulatory regime for medical devices, preclearance review of some devices with the extent of premarket review depending on the novelty and potential hazards of the devices, and expansion of the FDA’s nonpreclearance authority over medical devices. The last category included mandatory records and reports, adherence to good manufacturing practices, manufacturer registration, and FDA inspection of factories.13

Over the next few years, several high-profile public-health problems that involved medical devices were observed. Among the most publicized was the Dalkon Shield, an intrauterine contraceptive device (IUD) that was introduced into the market in late 1970. By 1975, at least 16 deaths, 25 miscarriages, numerous cases of pelvic perforation and pelvic infection, re-

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9FFDCA § 201(g)-(h), 52 Stat. at 1041 (1938).

10AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir. 1968), cert. denied, 393 U.S. 825 (1968).

11U.S. v. An Article of Drug … Bacto-Unidisk, 394 U.S. 784 (1969).

12H.R. REP. No. 94-853, at 9.

13H.R. Rep. No. 94-853, at 9-10; U.S. DEP’T OF HEALTH, EDUC., & WELFARE, MEDICAL DEVICES: A LEGISLATIVE PLAN passim (1970) (Cooper Committee Report).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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moval of the IUD for medical reasons, and pregnancies due to IUD failure had been reported. Marketing of the device ceased by 1976. Other examples cited by the House of Representatives committee responsible for the 1976 legislation included pacemaker failures and dangerous eye infections after implantation of intraocular lenses.14

In 1974 and 1975, the Senate passed comprehensive legislation for the regulation of medical devices.15 The House of Representatives, however, did not move with its own bill until March 1976.16 A conference committee reconciled the differences between the two bills.17 The Medical Device Amendments of 1976 (MDA) passed both houses of Congress and were signed into law by President Ford on May 28.18

As discussed below, the medical-device law has since been amended many times, most significantly in 1990, 1992, 1997, 2002, 2004, 2005, and 2007. None of those amendments, however, has altered the fundamental regulatory regime established in 1976.

BASIC STRUCTURE OF THE MEDICAL DEVICE AMENDMENTS

Although the new statute provided for premarket review of some products, protection of public health rested predominantly on rules enforced by the FDA after a product entered the market. In that respect, the MDA departed from the approach taken for drugs in 1962, which put extraordinary emphasis on the FDA premarket approval process as the primary means of protecting consumers. For devices, the “gatekeeper” function of premarket approval provided an additional layer of protection but only for a small array of products (Class III), and it did not replace or render unnecessary the variety of other requirements applicable to all other devices. As originally enacted, the 510(k) clearance process was not intended to be a major preclearance mechanism.

Distinguishing Devices from Drugs

To establish a distinctive regulatory scheme for medical devices, Congress first had to address the overlapping definitions of drug and device in the 1938 law. As noted above, federal courts found the terms sufficiently congruent to uphold the FDA’s determination that several products thought

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14H.R. Rep. No. 94-853, at 8 (1976).

15S. Rep. No. 94-33, at 1 (1975) (accompanying S. 510).

16H.R. Rep. No. 94-853, at 1 (accompanying H.R. 11124).

17H.R. Rep. No. 94-1090, at 1 (accompanying S. 510).

18Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) (hereinafter 1976 MDA).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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of as devices could nevertheless be regulated as drugs. The MDA provided as follows

The term “device” … means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

1. recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. intended to affect the structure of any function of the body of man or other animals,

and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.19

General Controls

The MDA established requirements for industry and authorities for the FDA that would apply to all medical devices. Those provisions are usually described as the general controls and include the following:20

•    Applying to all devices the “adulteration” provisions of the 1938 Act, including—

o    prohibiting potential or actual contamination of the product;21 and

o    requiring adherence to good manufacturing practice regulations promulgated by the FDA.22

•    Applying to all devices the “misbranding” provisions of the 1938 Act, including—

o    prohibiting any false or misleading statements in labeling,23

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19FFDCA § 201(h), 90 Stat. 575 (1976). The definition was changed in 1992 to substitute “its primary intended purposes” for “any of its principal intended purposes.” 106 Stat. 240 (1992). For current definition see FFDCA § 201 (h), 21 USC § 321(h) (2006).

20This summary necessarily abbreviates the statutory language. It is intended to give an overview, not provide a detailed description of each provision of the law.

21FFDCA § 501(a)(1), (a)(2)(A), (3), (4)(A), 21 USC § 351(a)(1), (a)(2)(A), (3), (4)(A) (2006).

22FFDCA §§ 501(h), 520(f), 21 USC §§ 351(h), 360j(f) (2006).

23FFDCA § 502(a), 21 USC § 352(a) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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o    requiring disclosure of the name and address of the manufacturer,24 and

o    mandating “adequate directions for use” and “adequate” warnings against unsafe use in labeling for the product.25

•    Authorizing the FDA to restrict the sale, distribution, or use of a device (a) only on the authorization of a licensed practitioner or (b) upon such other conditions as the FDA may prescribe, if—because of the potential for harm or the collateral measures necessary to its use—the FDA determines that there cannot otherwise be reasonable assurance of the safety and effectiveness of the device (devices so designated are called “restricted devices”).26

•    Prohibiting false or misleading advertising of a “restricted device.”27

•    Mandating disclosures in all advertising for “restricted devices” of a brief statement of intended uses and relevant warnings.28

•    Requiring registration with the FDA by all manufacturers of medical devices.29

•    Mandating listing with the FDA by a registered firm of all devices it currently markets.30

•    Requiring notification to the FDA of any new device proposed to be marketed by a registered firm, at least 90 days prior to introduction for commercial distribution [this is the provision that gave rise to the 510(k) process that is the focus of the committee’s study].31

•    Authorizing the FDA to inspect factories in which medical devices are manufactured and to inspect records relating to “restricted devices” in those facilities.32

•    Authorizing the FDA to ban a device from sale or use if it presents substantial deception or an unreasonable and substantial risk of illness or injury.33

•    Authorizing the FDA to order notification to physicians and others (including patients and other end users) if three conditions are all met: (a) a device presents an unreasonable risk of substantial harm to the public health, (b) notice is necessary to eliminate the risk, and (c) no other more practicable means is available to eliminate this risk.34

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24FFDCA § 502(b), 21 USC § 352(b) (2006).

25FFDCA § 502(f), 21 USC § 352(f) (2006).

26FFDCA § 520(e), 21 USC § 352(e) (2006).

27FFDCA § 502(q), 21 USC § 352(q) (2006).

28FFDCA § 502(r), 21 USC § 352(r) (2006).

29FFDCA § 510(c), 21 USC § 352(c) (2006).

30FFDCA § 510(j)(1), 21 USC § 360(j)(1) (2006).

31FFDCA § 510(k), 21 USC § 360(k) (2006).

32FFDCA § 704(a), 21 USC § 374(a) (2006) (2006).

33FFDCA § 516, 21 USC § 360f (2006).

34FFDCA § 518(a), 21 USC § 360h(a) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

•    Authorizing the FDA to order a manufacturer to repair a device, replace the device, and/or refund the purchase price of the device, if four conditions are all met: (a) the device presents an unreasonable risk of substantial harm to the public health, (b) the device was not properly designed or manufactured to the state of the art when designed or made, (c) the unreasonable risk was not caused by someone other than the manufacturer to exercise due care with the installation, maintenance, or use of the device, and (d) notification by itself would not be sufficient to eliminate the unreasonable risk, so that repair, replacement, and/or refund by the manufacturer is necessary to eliminate this risk.35

•    Authorizing the FDA to require manufacturers to maintain records and submit reports (such as reports of adverse medical events associated with medical devices) to assure that a device is not adulterated or misbranded and to otherwise assure its safety and effectiveness36 (the statute presumed, however, that Class I devices would not be subject to reporting in ordinary circumstances).37

•    Authorizing the FDA to order detention of a device for up to 20 days, if the agency believes it is adulterated or misbranded, to permit the preparation and filing of a court action for seizure of the product.38

It must be emphasized that the foregoing requirements and authorities were established in 1976 almost always without regard to the assignment of a medical device into Class I, Class II, or Class III (the classes are defined below). The law has since been amended to exempt many Class I products from some general controls or to limit the application of general controls to subsets of Class II or III products that pose higher risks. But the original MDA rarely made those distinctions. In cases in which authority was conditioned on an FDA finding of a higher degree of risk, the finding was to be made without regard to the prior classification of the device.

Device Classification and Premarket Review

The 1976 act adopted a three-tier system to determine the need for additional regulatory controls in the form of premarket review to protect and promote public health. The tiers correspond to the perceived risks posed by the devices. Thus, the law represented a sharp break with the approach

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35FFDCA § 518(b), 21 USC § 360h(b) (2006).

36FFDCA § 519(a), 21 USC § 360i(a) (2006).

37FFDCA § 519(a)(8), 21 USC § 360i(a)(8) (2006) (redesignated from 519(a)(5) by the Medical Device Amendments of 1992, Pub. L. No. 102-300, § 5(a)(1), 106 Stat. 238, 239 (1992) (hereinafter 1992 MDA).

38FFDCA § 304(g), 21 USC § 334(g) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

taken with respect to pharmaceutical agents, for which a uniform and rigorous system was established for all new agents and an only slightly less demanding and uniform system for generic copies of these agents. Because of the wide variety among devices, Congress recognized that uniformity was neither necessary nor ideal to attain the ultimate public-health goal of a “reasonable assurance of the safety and effectiveness” of each marketed device.

Congress directed that the safety and effectiveness of a device be determined with respect to the persons for whose use the device is intended, with respect to the conditions of use in the labeling of the device, and by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.”39

A Class I device is one for which the general control requirements and any special control authorities that the FDA chooses to exercise with respect to the device would be sufficient to provide reasonable assurance of safety and effectiveness. Class I could also include any device on which there is insufficient information to judge the adequacy of general controls but that is not represented to be for use in supporting or sustaining human life (or preventing impairment to health) and does not present an unreasonable risk of illness or injury.40

A Class II device is one that cannot be classified into Class I (because the general controls are not sufficient by themselves to provide reasonable assurance of safety and effectiveness) but on which there is sufficient information to establish a performance standard or other special controls to provide reasonable assurance.41 A performance standard might include provisions regarding the construction, components, ingredients, and properties of the device and its comparability with power systems; provisions for the testing of the device to ensure conformity to the standard; provisions for measurement of performance characteristics of the device; provisions making the device a “restricted device”; and special labeling requirements related to the installation, maintenance, operation, and use of the device.42 The statute was ambiguous as to whether performance standards were required (that is, necessary to provide reasonable assurance of safety and effectiveness that could not be provided by general controls alone) or discretionary. In the separate section setting forth the procedures for promulgation of performance standards, the MDA stated that the FDA “may” establish performance standards but did not mandate them for Class II devices.43 If general controls were by definition inadequate, the absence of performance

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39FFDCA § 513(a)(2), 21 USC § 360c(a)(2) (2006).

40FFDCA § 513(a)(1)(A), 21 USC § 360c(a)(1)(A) (2006).

41FFDCA § 513(a)(1)(B), 21 USC § 360c(a)(1)(B) (2006).

42FFDCA § 514(a)(2), 21 USC § 360d(a)(2) (2006).

43FFDCA § 514(a)(1), 21 USC § 360d(a)(1) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

standards must have meant that the safety and effectiveness of a Class II device could not be reasonably assured.

A Class III device is one that is represented for use in supporting or sustaining life (or for substantial use in preventing impairment of health) or that creates a potential unreasonable risk of illness or injury but that cannot be classified into Class I (because the general controls are inadequate to give reasonable assurance of safety and effectiveness) or Class II (because there is not sufficient information to determine that additional special controls would be sufficient to provide the requisite assurance).44

The MDA directed the FDA to classify all then-marketed medical devices (so-called preamendment devices) into one of the three classes on the basis of the criteria just outlined.45 The 1976 Amendments also provided mechanisms for the FDA to reclassify devices originally placed in Class III into lower classes when premarket review was no longer needed to ensure the safety and effectiveness of the device type.46 In addition, the MDA provided that devices that were not on the market when the bill became law (so-called postamendment devices) would be automatically placed in Class III—at least until reclassified.47

Classification governed the type and extent of FDA review before a product could enter the market. Class III devices were subject to the most intense scrutiny.

For Class III devices, Congress required affirmative FDA approval before marketing.48 An application for PMA must contain the following major elements: full reports of all information, known or reasonably known to the applicant, regarding investigations to assess the safety and effectiveness of the device (including clinical investigations of safety and effectiveness); a full statement of the components and properties of the device and of the principles of its operations; a full description of the methods used in and facilities and controls used for its manufacture, processing, and (when relevant) packaging and installation; specimens of the labeling proposed to be used for the device; and any other information relevant to the PMA that the FDA (with the concurrence of an advisory panel) may require.49 The 1976 statute did not provide the FDA any explicit authority to waive those requirements. The agency was given 180 days to review a PMA and grant or deny its approval.50 During the review process, the FDA could on

____________

44FFDCA § 513(a)(1)(C), 21 USC § 360c(a)(1)(C) (2006).

45FFDCA § 513(b)–(d), 21 USC § 360c(b)–(d) (2006).

46FFDCA § 513(e), 21 USC § 360c(e) (2006).

47FFDCA § 513(f)(1), 21 USC § 360c(f)(1) (2006).

48FFDCA §§ 513(a)(1)(C), 515(a), 515(a), 21 USC §§ 360c(a)(1)(C), 360e(a) (2006).

49FFDCA § 515(c), 21 USC § 360e(c) (2006); see 21 CFR § 814.20 for the FDA’s regulations detailing the required format and contents of a PMA.

50FFDCA § 515(d)(1), 21 USC § 360e(d)(1) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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its own initiative (and, on request of an applicant, would have to) refer the PMA to an outside advisory panel, which would report its conclusions and recommendations.51 Grounds for denial include the lack of showing of a reasonable assurance of either safety or effectiveness, noncompliance with good manufacturing practices, or false or misleading labeling.52 The FDA could condition approval on compliance with one or more of a variety of postapproval requirements, including the completion of studies to confirm the safety, effectiveness, and reliability of the device for its intended use.53 Once a PMA was approved, the applicant had to obtain additional FDA approvals before making changes in the labeling of the device, its indications for use, its packaging or sterilization procedures, the performance or design specifications, its components, principles of operation, physical layout, or method of manufacture.54

For Class I devices, the 1976 law contemplated that the sponsor of a new product that was classified in Class I would submit a notice to the FDA at least 90 days before marketing; the notice would set forth the simple fact that the device was so classified. That notice became known as a 510(k) notification after the section of the MDA that required a manufacturer to notify the FDA of a new product before marketing it.55 If the agency concurred or failed to respond within 90 days, the product could enter the market; otherwise, the sponsor was notified that the product could not enter the market without further action being taken (for example, approval of a PMA).

For premarket review of a Class II device, the 1976 law seemed to contemplate that the sponsor of a new product would submit to the FDA a notice under Section 510(k) setting forth the fact that the device was classified in Class II and, if a performance standard had been promulgated, appropriate certification or evidence that the product conformed to the standard.56 Again, the FDA would review the notice and determine whether it agreed.

The classification of preamendment devices did not include any evaluation of the safety or effectiveness of the individual medical devices. The FDA created advisory panels to assist in the device classification process. These panels reviewed information on the risks posed by types of devices, including the potential risks resulting from a failure of lack of effectiveness, and recommended into which class the device type should be placed, in order to provide a reasonable assurance of safety and effectiveness. Neither the panels nor the FDA itself undertook an assessment of the clinical safety or

____________

5121 CFR § 814.44(a), (b).

52FFDCA § 515(d)(2), 21 USC § 360e(d)(2) (2006).

5321 CFR § 814.82.

54FFDCA § 515(d)(6), 21 USC § 360e(d)(6) (2006); limited exceptions are provided in 21 CFR § 820.39(d).

55FFDCA § 510(k), 21 USC § 360(k) (2006).

56FFDCA § 510(k), 21 USC § 360(k); § 514(a)(1)(B), 21 USC § 360d(a)(1)(B).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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effectiveness of individual devices during the original classification process. Once a device type was assigned to Class III, the statute directed the FDA to promulgate a regulation calling for manufacturers of devices of that type to submit a PMA application. The agency would then (and only then) undertake a review of the safety and effectiveness of the specific devices. For device types placed into Class I or Class II, there was no mechanism for the systematic post-classification review of safety and effectiveness. Congress envisioned instead that the agency would use its postmarketing tools to identify and address issues of lack of safety or lack of effectiveness case by case.

In short, device classification was established in the MDA primarily in relation to premarket review. Class I devices needed no additional review once a device’s status as Class I was confirmed; the general controls were sufficient to protect public health. Class II devices needed only limited supplemental review to verify conformity with any established performance standard. Class III devices, the truly novel devices that presented significant risks to health, were the only ones that Congress wanted to undergo premarket FDA scrutiny similar to that of new drugs.57

Transition Problems

Congress wanted the new standards of safety and effectiveness to be applied to the Class III devices that were already in the marketplace in 1976. Whenever Congress requires such a retrospective review of existing products, however, it faces a series of challenges:

•    Should the law permit continued marketing of the existing products while they are undergoing the new review? Immediate suspension would disrupt routine activities; in the case of medical products, it would deny healthcare professionals and patients access to previously available technologies.

•    If existing products can continue to be marketed, should the law also permit new products that are identical (or nearly so) to be launched before the review of the existing products has been completed? On one hand, introduction of new products can proliferate the use of the technology before it has been assessed. On the other hand, giving the existing products a monopoly (by excluding competitors until completion of the retrospective review) is unfair to newcomers and creates perverse incentives for the incumbent manufacturers to slow the review process.

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57By 1976, the FDA was asserting that virtually all prescription drug products were considered to be new drugs, including all those which had entered the market after 1938, even if they entered without approval of an NDA (such as generic versions of previously approved drugs). See Vodra, 1981.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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•    If marketing is permitted to continue during the transition period, should the law impose a deadline for completion of the review? Without a deadline, the temporary exception could become a permanent grandfather clause under which the existing products (and equivalent newcomers if permitted) are exempt from the review process indefinitely—perhaps until the products become obsolete. Moreover, without a deadline, manufacturers of products that might not pass the review have a strong interest in prolonging the transition for as long as possible.

In three prior amendments to the 1938 FFDCA, when Congress required a retrospective review of products on the market at the time of the amendments, Congress had taken similar approaches to those issues. In all cases, existing products had been allowed to remain in the market during review of the new products, and competitors were allowed to enter the market before completion of review and retroactive application of new regulatory standards. The earlier amendments tried different approaches to ensure that the review was completed with reasonable dispatch, but none was fully successful. In every case, the statutory deadline was not met (IOM, 2010, pp. 3–6).

In the MDA, Congress directed the FDA to promulgate regulations for each type of Class III device that would require approval of a PMA. The issuance of the individual regulations was to follow a timetable established by the FDA. In the meantime, however, the preamendment products could remain on the market pending the promulgation of the regulation calling for the PMA and its submission and review.58 During the transition period for each type of Class III device, new (postamendment) products of the same type would also be permitted to enter the marketplace.59 But the manufacturer of a postamendment device would not have to submit and obtain approval of a PMA before the manufacturers of the preamendment were required to. Instead, the manufacturer would submit a 510(k) notification demonstrating that its proposed product was “substantially equivalent” to a Class III preamendment device. Once PMA requirements were imposed, however, the use of the 510(k) would terminate. The 510(k) notification process was a purely transitional tool for Class III devices, which would end as the PMA requirements were fully implemented.

Another part of the 1976 amendments provided that all postamendment devices were automatically to be classified into Class III with specific exceptions.60 The primary exception involved a postamendment device that was substantially equivalent to another device of the same type that either was

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58FFDCA § 515(b)(1), 21 USC § 360e(b)(1) (2006).

59FFDCA § 513(f)(4), 21 USC § 360c(f)(4) (2006).

60FFDCA § 513(f)(1), 21 USC § 360c(f)(1) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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a preamendment device that had not been classified into any class or was not a preamendment device but had already been classified into Class I or Class II.61 The FDA permitted manufacturers of postamendment devices to demonstrate substantial equivalence to a preamendment device in Class I or II as part of the 510(k) submission. An alternative exception provided that the postamendment device would not be in Class III if the FDA, in response to a petition, classified it into Class I or Class II.62

Congress assumed that ultimately postamendment devices would also be classified, on the basis of risk, into the appropriate category. But until then, any new product proposed for marketing after 1976 would be subject to PMA requirements unless it was substantially equivalent to a preamendment device already in Class I or Class II (or not yet classified) or was reclassified by the FDA down from Class III. That particular provision could place enormous resource demands on the agency as technology evolved and newer devices were developed. The FDA might have to either process increasing numbers of PMAs or reclassify the new devices into Class I or II through a procedurally cumbersome, labor-intensive, and time-consuming process.

There was another pathway: The agency might determine that the proposed new device was substantially equivalent to a device classified in Class I or II, notwithstanding the changes in technology, and permit it to be marketed pursuant to a 510(k) notification.

Definition of Substantial Equivalence

Congress did not define substantial equivalence in the legislation, but the House committee report contained the following statement:

The term “substantially equivalent” is not intended to be so narrow as to refer only to devices that are identical to marketed devices nor so broad as to refer to devices which are intended to be used for the same purposes as marketed products. The Committee believes that the term should be construed narrowly where necessary to assure the safety and effectiveness of a device but not so narrowly where differences between a new device and a marketed device do not relate to safety and effectiveness. Thus, differences between “new” and marketed devices in materials, design, or energy source, for example, would have a bearing on the adequacy of information as to a new device’s safety and effectiveness, and such devices should be automatically classified into class III. On the other hand, copies of devices marketed prior to enactment, or devices whose variations are immaterial to safety and effectiveness would not necessarily fall under the automatic classification scheme.63

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61FFDCA § 513(f)(1)(A), 21 USC § 360c(f)(1)(A) (2006).

62FFDCA § 513(f)(1)(B), 21 USC § 360c(f)(1)(B) (2006).

63H.R. Rep. No. 94-853, at 36-37.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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The MDA did not spell out the required contents of a 510(k). Generally, however, a 510(k) would not have to contain a description of the components and properties of a device, the principles of its operations, the methods of manufacture, or specimens of the labeling proposed to be used for the device. It need only set forth its proposed intended use or indications for use, the device to which substantial equivalence is claimed, and evidence demonstrating that equivalence.

IMPLEMENTATION OF THE MEDICAL DEVICE AMENDMENTS: LONG-TERM TRENDS

Resource Limitations

Two overarching factors have affected the FDA’s efforts to carry out the MDA. First, the agency never had sufficient resources to fulfill all the congressional directives for medical-device classification and regulation. Although a continuous and consistent dataset of funding and staffing from FY 1976 to FY 2010 is not available, there are snapshots. The information that follows compares “apples, oranges, and other fruit” and can be viewed only as an approximation of the resources over time.

In FY 1981, FY 1982, and FY 1983, the numbers of full-time equivalent (FTE) staff-years for the Bureau of Medical Devices and the Bureau of Radiological Health—which were merged in 1982 to form the National Center for Devices and Radiological Health, which is now CDRH—were 836, 786, and 779, respectively (GAO, p. 1983, 4). From 1982 to 1987, CDRH underwent a 5% staff reduction.64 In 1989, GAO reported that the FDA budget for FY 1990 would provide the agency with 430 FTE positions fewer than it had in FY 1980, a 5.5% reduction (GAO, 1989a, p. 12).

Later data are more detailed. Between FY 1990 and FY 1994, the numbers of FTEs assigned to the 510(k) program were 120, 131, 126, and 140 (GAO, 1996, p. 35). From FY 1991 to FY 1994, the median time required by the FDA to complete 510(k) reviews increased from an average of just under 90 days to more than 160 days, then up to 230 days, and finally down to 152 days, all well beyond the 90-day goal of the law (GAO, 1995, pp. 5–6). In the next 2 fiscal years, FY 1995 and FY 1996, the number of FTEs assigned to the 510(k) program rose to 186 and 211, respectively—a 50% increase in just 2 years (GAO, 1996, p. 35). In those 2 fiscal years, the median 510(k) review time fell back to about 90 days (GAO, 1997b, p. 4).

A 2009 GAO report described the total staffing resources for the devices

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64Medical Devices and Drug Issues: Hearing Before the Subcomm. on Health and the Env’t. of the H. Comm. on Energy and Commerce, 100th Cong. 387 (1987) (statement of James S. Benson, Deputy Director, Center for Devices and Radiological Health, Food and Drug Administration, Department of Health and Human Services).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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program from FY 1999 to FY 2008. The number fluctuated around 1,500, with a low of 1,454 (FY 2002) and a high of 1,564 (FY 2008) (GAO, 2009a, p. 42). For premarket review within CDRH, including both 510(k) submissions and PMA applications, the number of FTEs increased in FY 2004–FY 2008 from 516 to 618.65 Thus, it appears that only in the past few years, with the adoption of user fees, have the resources committed to premarket reviews increased substantially.

Procedural Demands

The second fundamental factor affecting implementation was an increase in procedural steps needed for the FDA to take administrative actions.

Soon after taking office, President Reagan issued Executive Order 12291 on Federal Regulations to implement new controls over the issuance of regulations by all US agencies.66 It specified that agencies must have “adequate information concerning the need for and consequences of proposed government action” and must prepare a regulatory impact analysis for any major rule or regulation that could affect the economy, increase costs or prices, or substantially and adversely affect competition, productivity, or innovation. Moreover, regulatory action was permitted only if the potential benefits to society outweighed the potential costs, if the proposed action maximized the new benefits, and if alternative approaches had been considered to achieve the same objective at a lower net cost to society. To enforce those standards, OMB was required to review all proposed and all final major regulations before publication by an agency. The effect of the new controls was to increase the time and administrative burdens on the FDA to draft and issue regulations. The executive order is still in effect.

Soon after the issuance of Executive Order 12291, HHS Secretary Richard Schweiker issued an order that modified the delegation of authority to the commissioner of food and drugs to promulgate regulations implementing the FFDCA. The order reserved the secretary’s authority to approve the FDA regulations that addressed important public issues involving quality, availability, marketability, or cost of FDA-regulated products.67 This order is still in effect.

The MDA dictated that many agency actions be carried out only through proceedings involving the issuance of regulations or analogous procedures for soliciting public input and establishing final orders, for example, to classify or reclassify devices,68 to establish performance standards

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65Id. at 50.

66Exec. Order No. 12291, 46 Fed. Reg. 13,193 (Feb. 17, 1981).

6746 Fed. Reg. 26,052 (May 11, 1981) (2006).

68FFDCA § 513(c)–(f), 21 USC § 360c(c)–(f) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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for specific types of Class II devices,69 to require PMAs for specific types of preamendment Class III devices,70 to ban devices,71 to require records and reports from manufacturers,72 to restrict the sale or use of an individual device to medical practitioners,73 and to specify good manufacturing practices for manufacturers.74

The MDA’s requirements for promulgation of regulations often went beyond the basic requirements of the Administrative Procedure Act, which governs the promulgation of federal regulations generally. For performance standards for Class II devices, for instance, the MDA required that five separate notices be published in the Federal Register: a notice initiating proceedings to establish a performance standard, which provided manufacturers an opportunity to request a change in classification in lieu of a standard; a notice inviting submission of existing voluntary or industry standards as a proposed FDA standard and offers to develop the standard; a notice accepting or rejecting offers and announcing a decision to proceed with a standard; a notice proposing a standard and inviting comments; and a notice promulgating the final standard.75 If it were requested by a manufacturer, the FDA had to convene an advisory committee to review the proposed standard before issuing a final order.76 In the wake of Executive Order 12291, the FDA also decided that before it would initiate a proceeding to establish a performance standard, it would consider the following alternative steps: requesting that manufacturers voluntarily solve device problems, publicizing particular device problems, publishing educational and technical information, participating in developing a voluntary standard, using other general controls, and developing guidelines.77 It should surprise no one, therefore, that the FDA did not promulgate a single Class II performance standard in the period 1976–1990 and has adopted very few since.

The effect of those procedural burdens is also illustrated by the FDA’s implementation of the MDA’s restricted-device provision. Congress empowered the agency to issue regulations imposing restrictions on the sale,

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691976 MDA § 514 (b)–(e) (removed by the Safe Medical Devices Act of 1990, Pub. L. No. 101-629 § 6(a)(2), 104 Stat. 4511, 4519-20 (1990) [hereinafter SMDA]).

70FFDCA § 515(b), 21 USC § 360e(b) (2006).

71FFDCA § 516(a), 21 USC § 360f(a) (2006).

72FFDCA § 519(a), 21 USC § 360i(a) (2006).

73FFDCA § 520(e), 21 USC § 360j(e) (2006).

74FFDCA § 520(g), 21 USC § 360j(g) (2006).

751976 MDA § 514 (b)–(g), 90 Stat. 539 (Subsections (b)–(f) were removed by SMDA § 6(a)(2); Subsection (g) is now codified as 21 USC § 360d(b) (2006)).

761976 MDA § 514(g)(5) (now codified as 21 USC § 360d(b)(5) (2006)).

77FDA Bureau of Medical Devices, Policy for Class II Medical Devices (August 1982) (unpublished internal draft, cited in OFFICE OF TECH. ASSESSMENT, CONGRESS OF THE UNITED STATES, FEDERAL POLICIES AND THE MEDICAL DEVICES INDUSTRY 109-110, 250 n. 387 (1984)).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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distribution, or use of a device.78 Once a device was declared restricted, the FDA was authorized to regulate its advertising and promotion and to inspect its manufacturing records.79 Before the MDA’s enactment, many devices were marketed as “prescription devices” that could be sold only to or on order of or used only by a physician. One week after President Ford signed the bill into law, the FDA published a notice in the Federal Register declaring that existing prescription devices were now “restricted devices.”80 Several device manufacturers challenged the FDA’s legal position, and federal courts ruled that the FDA had to use formal notice-and-comment rule-making to declare devices restricted.81 In response, the FDA proposed a rule on restricted devices in October 1980, observing that the decision of whether a device was a prescription device was often made by individual manufacturers without consistent standards or objective criteria.82 A year later, however, the FDA withdrew the proposed rule, stating that comments argued that the existing system for designating devices as prescription-only devices was adequate and that Executive Order 12291 directed the FDA not to impose new requirements unless the benefits outweighed the costs.83 The agency went on to say that it would rely on its other authorities, such as its power to inspect records that were required to be kept under the good-manufacturing-practice regulations and under the dispensing and labeling requirements for prescription and nonprescription devices. The FDA has not attempted since 1981 to issue regulations under the MDA’s restricted-device provision although it has used its authority to designate individual devices as restricted in conjunction with PMA approvals84 and with special controls on some Class II devices.85

Effects of Resource and Process Constraints

The consequences of inadequate resources and elaborate procedural requirements were predictable. The FDA did not complete many of the mandates of the MDA. For example, by 1987, the FDA had not completed the classification of pre-1976 devices (a task finished in 1988 [Hutt et al., 2007, supra note 11, 986]), had not promulgated any performance standards for any of the roughly 1,100 types of devices placed in Class II, and had not

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78FFDCA § 520(e), 21 USC § 360j(e) (2006).

79FFDCA § 502(q)–(r), 21 USC § 352(q)–(r); § 704(a), 21 USC § 374(a) (2006).

80Implementation of the Medical Device Amendments of 1976, 41 Fed. Reg. 22,620 (June 4, 1976).

81Becton, Dickinson & Co. v. FDA, 589 F.2d 1175, 1182 (2d Cir. 1978); In re Establishment Inspection Portex, Inc., 595 F.2d 84, 86-87 (1st Cir. 1979).

8245 Fed. Reg. 65,619 (Oct. 3, 1980).

8346 Fed. Reg. 57,568 (Nov. 24, 1981).

84FFDCA § 515(d)(1)(B)(ii), 21 USC § 360e(d)(1)(B)(ii) (2006).

85FFDCA § 514(a)(2)(B)(v), 21 USC § 360d(a)(2)(B)(v) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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called for PMAs for any of some 140 preamendment Class III devices.86 As discussed below, even after amendment of the MDA in 1990 to ease the burdens on the FDA, the problems in completing implementation of the MDA remained a major concern to Congress. The Subcommittee on Health and the Environment of the House Committee on Energy and Commerce requested an audit by GAO regarding the FDA’s rule-making process in 1990. In April 1992, the subcommittee held a hearing devoted to that subject, citing delays in issuing regulations called for by various FDA statutes passed in 1983, 1984, and 1990. The chairman opened the hearing by stating that “the most troubling area of concern is implementation of the 1976 medical device amendments.”87 As a result of the FDA’s delays in issuing a particular regulation called for by the 1990 amendments to the MDA, Congress was compelled to pass a new law in June 1992 to revise the 1990 amendments to provide additional time for implementation.88

The most important consequence of the combination of limited resources and burdensome administrative procedures was the evolution of the 510(k) clearance process from a transitional tool for preclearance of postamendment Class III devices and unclassified types of devices to a permanent and dominant means of premarket review of most devices. By broadening the concept of substantial equivalence, the FDA used the 510(k) system to avoid requiring PMAs for (or down-classifying) many new and novel devices that would have been placed in Class III. More than 80% of postamendment Class III devices had entered the market on the basis of a 510(k) showing substantial equivalence to a preamendment device.89 Moreover, many postamendment devices were being found substantially equivalent to preamendment devices in Class I or Class II notwithstanding substantial technologic changes. For example, computerization of many devices occurred under the 510(k) system (IOM, 2010, pp. 22–28). The result was that some 10 years after enactment most Class II and Class III devices still underwent a premarket review that appeared to be no more rigorous than that applied to Class I devices.90

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86Memorandum Re: Medical Device Hearing, May 4, 1987, Medical Devices and Drug Issues: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 100th Cong. 345 (1987) (referred to in the statement of Rep. Henry A. Waxman, Chairman, H. Subcomm. on Health and the Env’t).

87Food and Drug Administration Oversight: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 102d Cong., pt. 2, at 1 (1992).

881992 MDA, Pub. L. No. 102-300, 106 Stat. 238. The regulation related to reporting by user facilities of device-related adverse medical events.

89Memorandum Re: Medical Device Hearing, May 4, 1987, Medical Devices and Drug Issues: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 100th Cong. 344 (1987) (referred to in the statement of Rep. Henry A. Waxman, Chairman, H. Subcomm. on Health and the Env’t).

90Memorandum Re: Medical Device Hearing, May 4, 1987, Medical Devices and Drug

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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To understand why and how that situation came about, one must start with a literal reading of the MDA and a narrow interpretation of “substantial equivalence.” For a proposed postamendment device, the manufacturer was to submit sufficient information for the FDA to determine whether it was substantially equivalent to a preamendment device. If the FDA found that the new product was not substantially equivalent, it was automatically placed in Class III. The manufacturer would then have to submit a PMA or file a petition to reclassify the device into Class I or Class II.91 The PMA was totally new and untested but was perceived as likely to be burdensome for both industry and the FDA in cost and time to prepare and review. The alternative, device reclassification, was one of the processes for which Congress had demanded extensive notice-and-comment rule-making procedures and advisory-committee participation; in addition, a reclassification from Class III to Class II could be conditioned on the completion of additional lengthy procedures to establish a performance standard for the device.92

Both alternatives proved very demanding of FDA resources. In 1987, the agency told Congress that it estimated that the staff time needed to review a PMA was more than 1,200 hours on average. In contrast, the FDA said that it needed only 20 hours, on the average, to review a 510(k) submission.93 That is, for every two products required to undergo PMA review instead of 510(k) review, the FDA might need an additional full-time employee. At that time, the agency received more than 5,000 510(k) and 100 PMA submissions a year. If even 1% more of the new products were subject to PMA rather than the 510(k) clearance process, the FDA could need 25 additional employees. The agency also believed that issuance of performance standards for Class II devices would be even more burdensome, estimating that 40 staff-years (not staff-hours) would be required to develop a single performance standard (GAO, 1988b, p. 4).

Without more resources, the FDA chose to use the 510(k) clearance process as much as possible. To do that, the FDA implemented a liberal reading of substantial equivalence. In addition, it began to let manufacturers file 510(k)s that relied on a sequential chain of prior 510(k)s for postamendment devices to build the substantial equivalence to a preamendment device.

The FDA’s preclearance strategy was clearly described by Congress’s former OTA in a 1984 report:

____________________________________

Issues: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 100th Cong. 337 (1987) (referred to in the statement of Rep. Henry A. Waxman, Chairman, H. Subcomm. on Health and the Env’t).

91FFDCA § 513(f), 21 USC § 360c(f).

92FFDCA § 513(e), 21 USC § 360c(e).

93Medical Devices and Drug Issues: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 100th Cong., 384 (1987) (statement of James S. Benson, Deputy Director, Center for Devices and Radiological Health, Food and Drug Administration, Department of Health and Human Services).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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The 510k process, together with a determination of substantial equivalence, has been used extensively for postamendment devices to avoid Class III designation and its automatic requirement for premarket approval, or to avoid the involved rulemaking process necessary to reclassify such devices from Class III to Class I or II.

Use of the substantial equivalence clause to permit the marketing of devices without premarket approval has been encouraged by FDA’s regulations and practices. First [for product modifications, FDA limited the requirement for a 510(k) submission to] “changes that could significantly affect the safety or effectiveness of the device” [emphasis added]….

Second, FDA allows manufacturers to trace back through a chain of substantially equivalent postamendment devices to a device on the market before the amendments were enacted…. This practice has been labeled “piggybacking” or, alternatively, “equivalence creep”….

Third, the amount of data required to show substantial equivalence varies widely, depending on the device. (OTA, 1984, p. 104)

The data cited by OTA confirm the idea that the FDA seemed inclined to find substantial equivalence as often as possible (see Table A-1).

The percentage of 510(k) submissions found to be not substantially equivalent (NSE) has remained in the range of 2–4% throughout the life of the program. In the period FY 1988–1990, the percentage found NSE was about 2.0%.94 From FY 1989 through FY 1996, it continued in the same low range (see Table A-2).

In the period FY 2004–2009, the submissions found NSE were 3–4%, and the submissions subject to other disposition rose from 9% to 17% (FDA, 2010, p. 39).

The category “Other Disposition or Open” includes 510(k) submissions on which a final judgment of equivalence had not been made, those on which additional information was requested and the applicant could not respond in 30 days, those withdrawn by the applicant, those not accepted for filing by CDRH, those forwarded to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research for review, those deleted (for example, duplicates), those exempted by regulation from 510(k) review, those involving products that are not actively regulated (for example, a general-purpose article, an unfinished product, or not a device), and other administrative dispositions. It is possible that the percentage of

____________

94SUBCOMM. ON OVERSIGHT AND INVESTIGATIONS OF THE H. COMM. ON ENERGY AND COMMERCE, 103D CONG., LESS THAN THE SUM OF ITS PARTS: REFORMS NEEDED IN THE ORGANIZATION, MANAGEMENT, AND RESOURCES OF THE FOOD AND DRUG ADMINISTRATION’S CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 42 (Comm. Print 103-N).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

TABLE A-1 510(k) Submissions and Those Found Not Substantially Equivalent, 1976–1982

Year

No. 510(k)
Submissions

No. 510(k)
Submissions Found
Not Substantially
Equivalent

Percentage of 510(k)
Submissions Found
Not Substantially
Equivalent

1976 (7 months)

1,362

8

0.6%

1977

2,427

47

1.9%

1978

2,180

43

2.0%

1979

2,714

44

1.6%

1980

3,316

73

2.2%

1981

3,652

63

1.7%

1982

3,780

55

1.5%

Total

19,431

333

1.7%

SOURCE: Adapted from OTA 1984 p. 104

510(k) submissions that are found to be substantially equivalent is a better statistic by which to measure the success of the system in excluding inappropriate products from the market. This approach assumes, however, that all the “other dispositions” are the result of a likely finding of NSE, that is, that persons filing these 510(k) submissions withdraw them or fail to respond to questions because they recognize the futility of proceeding. This category undoubtedly includes 510(k) submissions that would ultimately have been judged NSE, but the available data do not permit further analysis.

The lack of volatility in the NSE rate over a 30-year period is remarkable, given that it covers different generations of reviewers and companies filing 510(k) submissions, emerging novel technologies, elimination of 510(k) reviews for most Class I devices, much higher average numbers of pages per submission, increasing demands for clinical and laboratory data, and evolving review practices and guidance. A congressional report in 1993 asserted, without citation, that CDRH had an “‘unofficial’ policy that disapproval of 510(k) submissions should not exceed 2 percent.”95 If true, that would support the view that, for at least some period, the FDA consciously sought to minimize its PMA workload by relying on the 510(k) clearance process. In any event, the history casts doubt on the reliability of a long chain of prior 510(k) clearances for making decisions today. If a product should have been processed by a PMA in the 1980s or 1990s but went through the 510(k) clearance process instead, any substantially equivalent product in 2010 must by law be cleared by the 510(k) clearance process.

____________

95SUBCOMM. ON OVERSIGHT AND INVESTIGATIONS OF THE H. COMM. ON ENERGY AND COMMERCE, 103D CONG., LESS THAN THE SUM OF ITS PARTS: REFORMS NEEDED IN THE ORGANIZATION, MANAGEMENT, AND RESOURCES OF THE FOOD AND DRUG ADMINISTRATION’S CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 39 (Comm. Print 103-N).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

TABLE A-2 510(k) Submissions and Those Found Not Substantially Equivalent, FY 1989–1996

Year No. 510(k) Submissions No. 510(k) Submissions Found Not Substantially Equivalent Percentage of 510(k) Submissions Found Not Substantially Equivalent No. 510(k) Submissions of Other Disposition or Open Percentage of 510(k) Submissions of Other Disposition or Open
1989 7,023 108 1.5% 1,657 23.6%
1990 5,835 142 2.4% 1,062 18.2%
1991 5,774 146 2.5% 1,115 19.3%
1992 6,533 202 3.1% 1,419 21.7%
1993 6,310 109 1.7% 1,449 23.0%
1994 6,450 96 1.5% 1,527 23.7%
1995 6,078 71 1.2% 1,218 20.0%
1996 5,316 43 0.8% 1,200 22.6%
Total 49,319 917 1.9% 10,647 21.6%

SOURCE: Adapted from GAO, 1997b, p. 7.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

Congressional Oversight of the Food and Drug Administration’s Implementation of the Medical Device Amendments in 1982–1990

Congress monitored how the 1976 amendments were implemented by the FDA through various arms: GAO, OTA, the Subcommittee on Health and the Environment and the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, and the Senate Committee on Labor and Human Resources. Reports and hearings demonstrate that many of the issues facing medical-device regulation now were identified and examined more than 2 decades ago.

1982–1983 Subcommittee on Oversight and Investigations Hearings and May 1983 Report

The Subcommittee on Oversight and Investigations conducted a hearing on the implementation of the MDA on July 16, 1982, and launched its own investigation.96 In the following year, the subcommittee issued a report titled Medical Device Regulation: The FDA’s Neglected Child.97 It was harshly critical of the agency, as can be seen in the chairman’s letter of transmittal to the committee, which described the report as “a picture of bureaucratic neglect for public health and safety that shocks the conscience,” opined that the FDA had shown “a cavalier disregard for the potential consequences” of its inaction, and cited many examples of “FDA’s derelictions in the device area.”98

The subcommittee made a series of findings, including99

1.Through negligence, or by intention, the FDA has failed to implement major provisions of the [MDA]:

a.   The agency has lost control of the medical device classification process, failing to complete in 6 years major tasks for which Congress allocated 1 year.

b.   The agency has not even begun to develop standards to assure safe, effective performance of class II devices.

c.   The agency has not required manufacturers of “old” class III devices to submit premarket approval applications.

d.   The agency has adopted no valid, reliable adverse experience report-

____________

96FDA Oversight: Medical Devices, Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 97th Cong. (1982).

97SUBCOMM. ON OVERSIGHT AND INVESTIGATIONS OF THE H. COMM. ON ENERGY AND COMMERCE, 98TH CONG., MEDICAL DEVICE REGULATION: THE FDA’S NEGLECTED CHILD (Comm. Print 98-F).

98Id. at iii–iv (Letter of Transmittal, John D. Dingell, Chairman, H. Subcomm. on Oversight and Investigations).

99Id. at 4.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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     ing system to inform the agency of device-related deaths, injuries, or device defects.

e.   The agency has used its significant new authority to notify professionals and users of devices of risks of harm a mere three times in 6 years, and it has used its authority to order repair, replacement, or refund but once.

2. The FDA is relying almost exclusively on “General Controls” to regulate devices when it previously determined that such general controls were inadequate.

3. As a consequence, the FDA is not equipped and, therefore, is unable to assure the American people that many medical devices currently on the market—and relied upon to treat disease and to sustain life—are safe and effective.

4. By failing to “restrict” devices in order to address problems caused through their misuse by inappropriately trained persons or in poorly equipped facilities, the FDA has failed to deal with the most frequent source of device-related injuries.

The subcommittee interpreted the MDA to compel performance standards for all Class II devices without discretion on the part of the FDA. The subcommittee also rejected an argument made by the FDA that performance standards might not be essential for Class II devices because there were no problems with the devices. In the subcommittee’s view, the absence of an effective system for identifying device-related adverse experiences precluded the FDA from drawing any such conclusion.100 It further rejected, as contrary to the risk-prevention approach adopted by Congress in the MDA,101 the idea of deferring performance standards until a public-health problem was identified.

The subcommittee made no specific legislative recommendations, but it did call attention to the “practical impossibility” of performance standards for each of the more than 1,000 types of Class II devices. It therefore suggested that “consideration be given to alternatives that recognize that although devices placed into Class II may pose significant risks to health, with respect to some devices those risks may be addressed by a species of controls less comprehensive than the mandatory performance standards now required by section 514.”102 One option identified was to divide Class II into two classes, for which one (Class II) would be required to have performance standards and the other (Class II-A) would not have to have

____________

100Id. at 15.

101Id. at 16.

102Id. at 5.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

performance standards but could be subject to greater regulatory controls than Class I devices (for example, classification as a restricted device or increased mandatory adverse-experience reporting).103 The primary problem, in the subcommittee’s view, was that the FDA had classified too many devices into Class II and some way had to be found to reduce the number subject to mandatory performance standards.104

September 1983 General Accounting Office Report

GAO issued a report to Congress titled Federal Regulation of Medical Devices—Problems Still to be Overcome in fall 1983 on the basis of a survey of 68 people in a variety of disciplines in the private sector who were considered experts on medical devices, including consumer groups, health care, biomedical research, bioengineering, law, trade associations, and manufacturing (GAO, 1983). The survey was designed to explore the extent of MDA implementation, the effects on innovation and manufacturing costs, and the general focus and extent of federal regulation. GAO also examined the FDA’s information systems and interviewed FDA officials.

GAO concluded that the FDA needed a comprehensive information system on the safety of medical devices in the marketplace; that development of performance standards for Class II devices—numbering more than 1,000 at that point—would be time-consuming and expensive, likely to become obsolete quickly, and perhaps unnecessary to ensure the safety and effectiveness of devices; that review of preamendment Class III devices would take many years; and that new risky devices in Class II and Class III were not being assessed for safety and effectiveness but only for substantial equivalence to preamendment devices. GAO observed, with regard to the 510(k) clearance process, that “FDA’s position is that ‘substantial equivalency’ does not require a determination of safety and effectiveness” (GAO, 1983, p. 55) and that the “major problem cited by experts we interviewed was that the substantial equivalence review provides no assurance of device safety and effectiveness” (GAO, 1983, p. 56).

Among its recommendations, GAO proposed that the FDA “(1) identify new Class II devices that pose health risks significant enough to require examination of safety and effectiveness data as part of an adequate finding of substantial equivalency and (2) develop guidelines for determining and documenting the safety and effectiveness of such devices” (GAO, 1983, p. 63). The FDA and its parent agency, HHS, disagreed with that particular recommendation, stating the following (GAO, 1983, pp. 75–76):

This [proposed] procedure would significantly alter the classification and

____________

103Id. at 17.

104Id. at 18.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

marketing procedures established in the amendments for Class II devices in a way not intended by the Congress.

*            *            *            *

As opposed to being a means for determining safety and effectiveness, the 510(k) process was intended by Congress to be simply a screening mechanism that would: (1) allow “substantially equivalent” post-Amendments devices to enter the market and be regulated like their pre-Amendment predecessors; and (2) identify “not substantially equivalent” post-Amendments devices and automatically place them in the premarket approval category….

We also believe FDA is applying the “substantial equivalency” test in a manner consistent with Congressional intent, though Congress’ instructions are not explicit on the interpretation of this term.

GAO’s response to the FDA’s comments was to reaffirm its recommendation and emphasize the deficiency in the current system (GAO, 1983, pp. v–vi, pp. 63–64):

GAO’s rationale for recommending safety and effectiveness documentation for certain Class II devices is similar to the reasons why safety and effectiveness reviews are necessary for Class III devices. In neither case has FDA determined the safety and effectiveness of the preenactment devices for which the new device is considered substantially equivalent. For Class III devices, FDA is required to make a safety and effectiveness determination for the preenactment device, but has not done so. For new Class II devices, FDA must determine whether they are substantially equivalent to a preenactment device, but is not required to establish whether the preenactment device is safe and effective. Consequently, a safety and effectiveness review is not conducted for either the substantially equivalent or preenactment device. Implementation of GAO’s recommendation would provide assurances that risky new Class II devices are safe and effective.

February 1984 House Subcommittee on Health and the Environment Hearing

On February 24, 1984, the Subcommittee on Health and Environment of the House Committee on Energy and Commerce held its first oversight hearing on implementation of the MDA.105 GAO presented a summary of its 1983 report and was followed by the FDA, represented by the acting

____________

105Medical Device Amendments of 1976: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 98th Cong. (1984) (cited in SUBCOMM. ON

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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commissioner and the director of CDRH. The FDA’s testimony highlighted these points:

•    The FDA was “considering the development of instructions that describe what constitutes appropriate content for a 510(k) submission.”106 In other words, in the first 8 years of the 510(k) program, there was neither a standardized format nor a set of required contents for these submissions.

•    Issuance of performance standards for all Class II devices was neither possible nor essential. First, it was too resource-intensive. “This assessment is based on the experience we have gained in the radiation area, where we have found, for example, that it takes roughly 40 person-years to develop a performance standard, and about 23 person-years annually to enforce it. [And] we have found that technological advances force us to revise many standards periodically, thus further depleting our resources.”107 “More important, it is unnecessary to develop federally mandated performance standards for all of these devices in order to protect the public health.”108

•    Down-classification of Class II device types to Class I, to avoid performance standards, would not reduce the resource burden. “In order to reclassify, the law requires that we assemble scientific evidence of safety and effectiveness, with a notice-and-comment rulemaking procedure in the Federal Register for each device.”109

•    Subdividing Class II into Class II and Class II-A, as suggested by the Subcommittee on Oversight and Investigations report of May 1983, “would still be too inflexible, simply substituting one set of requirements for another. Most important, the FDA does not need additional class II-A authority, since we already have sufficient authority under the general controls of class I to carry out any of the actions stipulated in the class II-A proposal [that is, imposing restrictions under the restricted-device provisions, increasing medical-device adverse-event reporting, and subjecting firms to periodic checking by FDA].”110

•    The FDA did request new legislation to eliminate what it perceived as a statutory obligation to promulgate performance standards for every

____________________________________

HEALTH AND THE ENV’T OF THE H. COMM. ON ENERGY AND COMMERCE, 98TH CONG., HEALTH AND THE ENVIRONMENT MISCELLANEOUS–PART 2 (Comm. Print 98-108)).

106Id. at 296 (statement of Mark Novitch, M.D., Acting Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services).

107Id. at 296–297.

108Id. at 297.

109Id.

110Id.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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     Class II device type. “Class II devices [are] those for which mandatory performance standards are presently required by the law.”111 “We believe that changes in the law are needed which would give [FDA] discretionary authority to select those devices requiring mandatory standards…. With the addition of discretionary authority, the Agency will be able to deal realistically with the class II device problem without compromising public health.”112

•    For Class II devices for which performance standards were needed, the process for establishing the standards should be streamlined.113

•    Although final regulations for manufacturer reporting of device-related adverse medical experiences—medical-device reporting (MDR)—had not yet been promulgated, even when in place they would not provide a complete picture. “In fact, many device problems in the field can be attributed to how the device is used, as opposed to how it is manufactured. Thus, we need a monitoring system which is complementary to MDR, but which relies on information from hospitals, practitioners, and consumers. This voluntary system, [which] we call the Device Experience Network, or DEN, is already in place, and is yielding approximately 2,500 reports per year, each of which is assessed, and many of which require action.”114

In his questioning, the chairman of the subcommittee noted that one of the major device-industry trade associations, the Health Industry Manufacturers Association (HIMA), was going to testify later in the hearing to the effect that the FDA was not required by the MDA to promulgate performance standards for all Class II devices. The FDA chief counsel set forth the FDA’s view of the law:

A device is placed in class II because a determination has been made that the class I general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.

That determination having been made and the device having been put into class II, you have got an outstanding determination that the controls provided under class I are insufficient, and a determination that a performance standard should be set for the device. We think that that combination of requirements appearing in the two classes … do not give us discretion to decline ever to promulgate a standard for a device that is in class II.

The argument that we do have such discretion is based on the initial

____________

111Id. at 305.

112Id. at 297.

113Id.

114Id. at 298.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

language of section 514, which says [FDA] may, by regulation, issue a performance standard. We don’t regard the word “may” there as giving us the discretion not to establish a performance standard.

We can rank order devices, and establish a priority list … but we think the act, as currently drafted, does contemplate that unless we are given the discretion to stop at some point, we have to keep going down that list and establish performance standards.115

The testimony of HIMA on this point presents a different view:

As to the nature of FDA’s standards-writing authority, we agree that there is ambiguity as to whether FDA must write standards for Class II products or whether it may write such standards…. The legislative history contains little to clarify explicitly this apparent contradiction, so we are left with attempting to reconcile these two statutory provisions.116

HIMA goes on to construct an argument that concludes that although the definition of Class II stated that a performance standard is necessary to provide reasonable assurance of safety and effectiveness, it does not require that this standard be promulgated by the FDA.117

March and September 1984 House Subcommittee on Oversight and Investigations Hearings

The Subcommittee on Oversight and Investigations held two hearings focused on device-related adverse-medical-experience reporting and the long delay in the FDA’s issuance of regulations to implement the authority conferred in the MDA in 1976.118 The FDA promulgated its MDR regulations, to take effect in 3 months (on December 14, 1984), just days before the second hearing, which was held on September 26, 1984.119 The subcommittee took credit for getting that action completed. The presiding representative, Albert Gore, said:

This subcommittee … is painfully aware of the history of this particular

____________

115Id. at 330 (answer of Thomas Scarlett, chief counsel, Food and Drug Administration, Department of Health and Human Services).

116Id. at 350 (testimony of the Health Industry Manufacturers Association).

117Id.

118Failed Pacemaker Leads: Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 98th Cong. (1984) (Comm. Print 98-134); Anesthesia Machine Failures: Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 98th Cong. (1984) (Comm. Print 98-188).

119Medical Device Reporting, 49 Fed. Reg. 36,326 (Sept. 14, 1984) (to be codified at 21 CFR pt. 600, 803, 1002-03).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

regulation. It was first proposed in November 1980, some 4 years after the passage of the law referred to earlier. Shortly after this administration took office, that regulation which had been proposed was pulled back and was sent to disappear into what I have referred to as the black hole of cost-benefit analysis, and the regulation remained in that black hole until the subcommittee’s 1982 hearings and the 1983 report.

On May 27, 1983, the agency reproposed the mandatory device reporting regulation. True to his word, then Acting Commissioner Novitch submitted the regulation to Secretary [of Health and Human Services Margaret] Heckler in March of this year, and there the regulation sat until on August 24 the subcommittee contacted Secretary Heckler again and said we are going to have another hearing; 3 days later, she signed the regulation, and it was at last published in the Federal Register.120

October 1984 Office of Technology Assessment Report

At the request of the Senate Committee on Labor and Human Resources in 1982, OTA, a congressional office that existed from 1972 to 1995 to provide objective and authoritative analysis of complex scientific and technical issues, convened an expert advisory panel to examine federal policies involving the medical-device industry. Its final report covered characteristics of the device industry, policies affecting payment for devices and health care, research on and development of devices, the use of medical devices, and regulation by the FDA (OTA, 1984). OTA made a number of salient observations about the 510(k) clearance process:

•    The FDA had used the 510(k) clearance process and its interpretation of substantial equivalence to avoid putting many products into Class III and the concomitant workload that PMA would necessitate (OTA, 1984, p. 104).

•    OTA was particularly concerned about the devices in Class II. More than 60% of the device types so far classified had been placed in Class II, and that suggested that it was a catch-all category, offering the appearance of more controls than the minimum requirements imposed on Class I while not subjecting products to the full demands that PMA required of a Class III device. The criteria for Class II were that general controls could not be expected to provide reasonable assurance of safety and effectiveness of a device and that there was sufficient evidence to establish a performance standard to provide

____________

120Anesthesia Machine Failures: Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 98th Cong. 39 (1984) (Comm. Print 98-188).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

     such assurance. But the FDA had not established a single performance standard and was unlikely to be able to promulgate many, because of the procedural requirements in the law. OTA opined that the “fact that no mandatory performance standards have been issued casts doubts on [the] conclusion” that the device types placed in Class II met the statutory criteria. “Regardless of whether or not the 1976 statute requires, rather than permits, the use of performance standards, the fact remains that, as a practical matter, there is little possibility that standards can be formulated for the large number of device types that have been placed in Class II. If performance standards were meant to be selectively used, the designation of so many device types as Class II and the resulting perception of the futility of such an exercise have been damaging to the FDA’s efforts, no matter what the rationale” (OTA, 1984, p. 120). Moreover, in the absence of performance standards, all Class II devices had been, in effect, regulated as though they were Class I devices (OTA, 1984, pp. 109–110).

•    Between 1977 and 1982, a total of 128 Class III products had gained PMA approval, and another 1,007 Class III products had entered the market via the 510(k) clearance process on findings of substantial equivalence to preamendment Class III devices that had yet to undergo PMA review for safety and effectiveness (OTA, 1984, pp. 112–114). Thus, almost 90% of the Class III products entering the market in this period were also in effect regulated as though they were Class I devices.

•    The FDA did not deem a 510(k) clearance either an approval for marketing or a finding of safety or efficacy. “FDA’s Office of General Counsel does not consider a finding of ‘substantial equivalence’ an approval. A device is considered approved once a determination is made that it is safe and effective. The 510(k) method of obtaining the FDA’s permission to market a device is basically a determination that the device is substantially equivalent to a preamendments device, and the FDA has no choice but to allow it to be marketed; it is not a determination that the device is safe and effective” (OTA, 1984, p. 128).

OTA laid out options for policy-makers to consider but did not recommend any specific actions. One option would “recognize the two-tiered regulatory approach that has been applied to medical devices rather than the three-tiered approach originally built into the law” (OTA, 1984, p. 127) Other options to reduce or eliminate the challenges of performance standards for all Class II devices were to give the FDA authority to use methods other than performance standards to regulate Class II devices, to create a new category in Class II that would be regulated through methods other

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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than performance standards, and to encourage the FDA to reclassify most Class II devices into either Class I or Class III.

OTA had an interesting perspective on the use of substantial equivalence. It believed that the practice would gradually fade away, stating:

as new generations of postamendments devices diverge more and more from their preamendments antecedents, it will be harder for manufacturers to use the substantial equivalence method of market entry. It will also be harder to practice “piggybacking,” in which a postamendments device is compared to another postamendments device and, through a chain of other postamendments devices, eventually compared to a preamendments device.

More immediately, FDA’s Office of Chief Counsel has stated that such “piggybacking” is not authorized by the amendments, and if the practice of piggybacking ceases, more postamendments devices will eventually be placed in Class III, and their manufacturers will have to go through the full premarket approval process or petition FDA for reclassification. (OTA, 1984, p. 130)

Thus, OTA assumed that existing procedures for determining substantial equivalence would be self-limiting. OTA offered two other options for consideration: eliminate the automatic classification of novel devices into Class III (allowing the FDA instead to make the initial classification at the time of initial notification) and develop procedures for reviewing modifications of commercially available devices distinct from procedures for reviewing new devices (assuming, apparently, that changes made in marketed products by existing suppliers raised fewer and narrower issues than the introduction of novel devices and new manufacturers) (OTA, 1984, pp. 130–131).

December 1986 General Accounting Office Report

The December 1986 GAO report was the first in a long series, stretching over more than 20 years, that has been critical of the FDA’s MDR system. GAO undertook a study of the FDA’s systems for monitoring device safety before the December 1984 implementation of mandatory manufacturing reporting of adverse experiences associated with medical devices. It found that hospitals report only about half the experiences to anyone (the FDA, manufacturers, or third-party organizations). Furthermore, information given to representatives of manufacturers rarely got to the companies’ central files, from where they might be sent to the FDA. It concluded that the FDA learns about less than 1% of hospital-based device-related injuries. GAO recommended that the FDA establish a voluntary postmarketing surveillance system involving a representative sample of hospitals (GAO, 1986).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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May 1987 House Subcommittee on Health and the Environment Hearing

On May 4, 1987, the Subcommittee on Health and the Environment held a hearing on the FDA’s implementation of the MDA.121 GAO testified before the FDA, focusing on the 1986 report, but adding that it did not believe that the FDA’s recent MDR regulations would solve the deficiencies identified in the report inasmuch as the agency was relying on reporting by manufacturers; too many opportunities existed for the communication of adverse-experience information to break down before it got to the manufacturer.122

The chairman of the subcommittee, in a memorandum to its members, identified a number of concerns, including the absence of performance standards for Class II devices, the failure of the FDA to require PMAs for preamendment Class III devices and reliance on the 510(k) clearance process instead, the paucity of postamendment devices approved by PMA, the apparent increase in device recalls, and MDR reports.123 He singled out the expansion of the concept of substantial equivalence in the 510(k) program, about which he stated:

As interpreted by FDA, section 510(k) permits post-1976 devices that have the same intended use as a pre-1976 device to enter the market so long as they are as safe and effective [as] the pre-1976 device.

Under FDA’s approach, devices that come onto the market fifty years after passage of the law will only have to demonstrate that they are as safe and effective as devices on the market before 1976. Even today, more than ten years after the law was passed, major technological improvements have occurred with many medical devices. Yet, under FDA’s 510(k) approach, new devices need not incorporate these improvements; they need only be as safe and effective as similar devices on the market before 1976.124

The FDA was represented by James Benson, deputy director of CDRH, who did not have prepared testimony but explained the actions recently taken by CDRH to address the issues of concern to the subcommittee. He testified that “it takes us [CDRH] 1200 staff hours to review a PMA,

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121Medical Devices and Drug Issues: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 100th Cong. 331 (1987).

122Id. at 365-83 (statement of Eleanor Chelimsky, General Accounting Office).

123Memorandum Re: Medical Device Hearing, May 4, 1987, Medical Devices and Drug Issues: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 100th Cong. 336-47 (1987) (referred to in the statement of Rep. Henry A. Waxman, Chairman, H. Subcomm. on Health and the Env’t).

124Id. at 339.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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but about 20 hours to review a 510(k)….”125 That statement has been cited ever since to distinguish the rigor of the PMA process from that of the 510(k) mechanism. The FDA has advised the present committee that it believes that those numbers are no longer accurate (Desjardins, 2011). Mr. Benson went on to say:

We basically … have taken a very hard look at the 510(k) clearance process. Only recently have we been able to get some guidance into the hands of the reviewers and … manufacturers…. That guidance basically says that a new product must be at least as safe as and as efficacious as prior products on the market [emphasis added].126

The chairman of the subcommittee asked Mr. Benson to confirm (which he did) that the FDA policy was that the “bottomline test is still the safety and effectiveness of the original [pre-1976] device.”127

July 1988 General Accounting Office Report

The chairman of the House Subcommittee on Health and the Environment asked GAO to evaluate the FDA’s estimates of the number of device-related adverse-experience reports that would follow if reporting by user facilities (for example, hospitals, ambulatory surgical centers, and nursing homes) were mandated and to evaluate the CDRH resource needs to process such reports. GAO reported that user reporting would increase the volume of reports but not permanently and that the FDA could achieve greater internal efficiencies in processing the reports (GAO, 1988a). (As will be seen below, 8 months later and again in 1997, GAO would reach different conclusions about the FDA’s resource requirements to operate the MDR system.)

August 1988 General Accounting Office Report

In response to another request of the chairman of the House Subcommittee on Health and the Environment, GAO undertook a study from 1986 to 1987 and issued a report in August 1988 titled Medical Devices: FDA’s 510(k) Operations Could Be Improved (GAO, 1988b). The report reflected GAO’s first in-depth examination of the 510(k) process as it operated. GAO found that the policies governing premarket notification were

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125Medical Devices and Drug Issues: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 100th Cong. 384 (1987) (statement of James S. Benson, Deputy Director, Center for Devices and Radiological Health, Food and Drug Administration, Department of Health and Human Services).

126Id. at 385.

127Id.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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generally adequate but that reviewing divisions differed concerning when to request additional information from 510(k) submitters. That observation suggested to GAO a lack of clear officewide policy and coordination among the divisions (GAO, 1988b, p. 3). It also identified deficiencies in internal documentation of 510(k) decisions (GAO, 1988b, p. 3). GAO recommended steps to improve consistency in decision-making and documentation practices (GAO, 1988b, p. 5).

GAO identified several problems with the 510(k) clearance process and its substantial-equivalence standard. First, GAO discussed the ambiguity of the term substantial equivalence:

The statute does not define or otherwise elaborate on the meaning of the term substantial equivalence. The relevant legislative history can be read in different ways. Under one reading, whenever a device about to be marketed varies from a pre-1976 device in its materials, design or energy sources, the product would be found not substantially equivalent and would be subject to premarket approval. Under a less restrictive reading, only variations that could, or do, materially affect safety or effectiveness should result in a “not substantially equivalent” decision. In any case, a determination of substantial equivalence in the premarket notification process does not mean that a device is safe and effective; it merely indicates that the device under review is not less safe and effective than a comparable pre-1976 device. (GAO, 1988b, pp. 2–3)

Second, it advised that relying on preamendment devices for determining substantial equivalence was problematic in that it excluded consideration of later superior devices. “If manufacturers can demonstrate that their devices are used for the same purposes and perform as well as products marketed prior to 1976, the FDA must [under current law] find the products to be substantially equivalent even if there are other products already on the market that ‘work better’” (GAO, 1988b, p. 4). GAO recommended that Congress amend the 1976 MDA to require the FDA to determine substantial equivalence on the basis of a comparison with a currently marketed device instead of a preamendment device (GAO, 1988b, p. 5). The auditors also suggested that Congress consider “clarifying the extent to which FDA should evaluate, within the premarket notification process, the effects of changes in medical devices on their safety and effectiveness” (GAO, 1988b, p. 5).

GAO underscored the absence of any performance standards for Class II devices and the high percentage of Class III devices for which PMA reviews of safety and effectiveness had not yet begun. The FDA advised GAO that the agency estimated that it took 1,200 staff-hours to review each PMA and 40 staff-years to develop a single performance standard (GAO, 1988b, p. 4). GAO observed that “additional resources will be required” for the

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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FDA to make more rapid progress in implementing these aspects of the 1976 amendments (GAO, 1988b, p. 4). Moreover, GAO observed that

because of these implementation problems, devices in class II and class III may be marketed through premarket notification without having to meet the additional requirements appropriate to their classification. As a result, FDA must place more reliance on premarket notification to control access of medical devices to the market than would otherwise be the case. (GAO, 1988b, p. 4)

To address that issue, GAO suggested that Congress might consider “developing alternative approaches to the regulation of devices currently placed in classes II and III” (GAO, 1988b, p. 5).

February 1989 General Accounting Office Report

Before the 1987 hearing, the chairman of the Subcommittee on Health and the Environment sought a GAO review of the FDA’s implementation of the MDR regulation. The report in response concluded that the MDR regulation had increased the number of device-related adverse-experience reports but that CDRH’s internal system could not handle the higher volume, so the potential effectiveness of the MDR regulation had not been fully realized. Moreover, GAO found that many manufacturers (perhaps one-third of those registered) were not aware of the MDR reporting requirements (which were effective in December 1984) and reporting across the industry was inconsistent, sometimes excessive, and often insufficient to comply with the rules. (GAO, 1989d, p. 2)

August and October 1989 General Accounting Office Reports

The chairman of the Subcommittee on Health and the Environment asked GAO to analyze medical-device recalls to identify the types of devices that had been recalled, the problems for which they were recalled, and the mode of market entry for the problem devices. GAO issued an interim report in August 1989 describing the data that had been gathered and a report in October providing further analyses (GAO, 1989b, 1989c). GAO found that design problems were the most common reason for Class I recalls;128 that many recalls were undertaken by manufacturers without notice to the FDA, so roughly half the Class I recalls were brought to the FDA’s attention from sources other than the manufacturers (for example, competitors, users, and FDA inspections); and that the device problems that led to the recalls often

____________

128FDA classifies recalls in reverse order of devices. Class I recalls denote the greatest immediate risk to the health, whereas Class I devices present the lowest inherent risk to health.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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were not reported to the FDA as MDRs, notwithstanding the requirement under the MDR regulations for such reporting.

November 1989 House Subcommittee on Health and the Environment Hearing

The Subcommittee on Health and the Environment held a hearing on legislation to address problems with the 1976 MDA and its implementation by the FDA.129

The first witnesses were from GAO, including the comptroller general, who heads that agency. He criticized the premarket testing and clearance of devices, citing four basic problems with the system as it was operating130:

One is that many of the pre-1976 devices were never tested themselves. Two, you have use of an old and often outdated comparison base. Three, you have a lack of definition of what is substantial equivalence. Four, [you have] FDA’s failure to develop standards for medium risk devices or to implement premarket requirements for high risk devices.

GAO also criticized the system of postmarketing surveillance on the basis of its recent reports to Congress.131

The acting FDA commissioner then testified. He commented on a proposed bill then pending before the subcommittee; the bill was a successor to a bill that passed the House in 1988 but died in the Senate. The acting commissioner commended the bill on many points, including codifying the FDA’s policies regarding substantial equivalence in the 510(k) clearance process and eliminating a requirement for the promulgation of performance standards for Class II devices. “The bill would give FDA discretion to apply one or more ‘special controls’ to a given device problem.”132 The agency, however, opposed the legislative proposal for user reporting of adverse device-related events as unnecessary and infeasible, stating that the system for manufacturer reporting was preferred by the FDA.133

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129Medical Device Safety: Hearings Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 101st Cong. (1989–1990).

130Id. at 33 (statements of Charles A. Bowsher, comptroller general, and Eleanor Chelimsky, assistant comptroller general, General Accounting Office).

131Id.

132Id. at 173 (statement of James S. Benson, Acting Commissioner, Food and Drug Administration).

133Id. at 177.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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February 1990 Subcommittee on Oversight and Investigations Hearing

The Subcommittee on Oversight and Investigations issued a report and held a hearing in February 1990 in which the FDA was severely criticized for failing to use the investigative and enforcement powers it already had and for failing to seek additional statutory authority that it needed in the regulation of the Bjork-Shiley heart valve.134 This hearing set the final political stage for the first revisions to the MDA.

July 1990 Department of Health and Human Services Inspector General Report,

The HHS inspector general reviewed the FDA’s internal controls over the 510(k) program at the request of the assistant secretary for health after the scandals that emerged in the late 1980s related to the FDA’s approval process for generic drugs. The inspector general audited the 510(k) clearance process to identify potential weaknesses that could lead to similar problems. The inspector general began by noting the purpose of the 510(k) system:

The primary objective of the premarket notification 510(k) clearance process is to determine whether a new or modified device is “substantially equivalent” to a device already on the market. A determination of substantial equivalence does not mean that a device is safe and effective; rather, it is an indication that the device is not less safe nor less effective than a comparable device.135

The final report covers a variety of concerns, two of which are related to the reliability of the decision-making process (and the validity of devices cleared earlier as proper predicates). The inspector general determined that the FDA

•    does not use certain critical information to make determinations of substantial equivalence, such as review of the product sample, verification of testing data, and premarket inspections of manufacturer facilities; [and]

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134STAFF OF SUBCOMM. ON OVERSIGHT AND INVESTIGATIONS OF THE H. COMM. ON ENERGY AND COMMERCE, 101ST CONG., THE BJORK-SHILEY HEART VALVE: “EARN AS YOU LEARN”–SHILEY INC.’S BREACH OF THE HONOR SYSTEM AND FDA’S FAILURE IN MEDICAL DEVICE REGULATION (Comm. Print 101-R); FDA and the Medical Device Industry: Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 101st Cong. (1990).

135Memorandum Re: Internal Control Weaknesses in the Food and Drug Administration’s Medical Device 510(k) Review Process, from the HHS inspector general to the HHS assistant secretary for health (July 5, 1990) 1, fn. 1

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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•    lacks a comprehensive quality control program to independently evaluate and critique the adequacy of reviewed submissions….136

THE SAFE MEDICAL DEVICES ACT OF 1990

The House had originally passed new device legislation in 1988, but the Senate took no action. In October 1990, both the House and Senate passed bills to revise the MDA; these were reconciled in conference, and a final bill, the Safe Medical Devices Act of 1990 (SMDA 1990), passed Congress and was signed into law on November 28.137

The initial House report on the bill explained the goal of the legislation as follows:

Since the comprehensive medical device law was enacted in 1976, difficulties have persisted in the implementation of the law. These implementation problems appear to be the result of: (1) complexities in the law; (2) the manner in which FDA interpreted certain provisions of the 1976 law; and (3) limited resources. The purpose of this legislation is to modify the underlying law in ways that will result in greater protection of the public health.138

The 1990 legislation included provisions that restructured the premarket-review scheme and separately expanded the scope of the “general controls” applicable to devices without regard to their classification.

Changes in Premarket Review Processes

The SMDA took a variety of steps to modify the original 1976 MDA structure for assessing the safety and effectiveness of devices before marketing. The three most relevant to the present discussion involve the regulatory standards and related requirements that differentiate Class I and Class II devices, the definition of substantial equivalence, and the retrospective review of the safety and effectiveness of preamendment Class III devices.

Definition of Class II; Replacement of Mandatory Performance Standards Requirements for All Class II Devices with Discretionary Special Controls Authority

Congress recognized both that the FDA had been unable to promulgate performance standards and that performance standards were not necessar-

____________

136Id. at 2.

137SMDA, Pub. L. No. 101-629, 104 Stat. 4511.

138H.R. Rep. No. 101-808, at 13 (1990); see also S. Rep. No. 101-513, at 14-15 (1990).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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ily the best or only regulatory tool to ensure the safety and effectiveness of devices for which general controls were not sufficient. Moreover, other tools might permit devices to be placed in Class II when, without the availability of such tools, Class III status would be necessary. Accordingly, it revised the definition of Class II to read as follows:

A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510(k)), recommendations, and other appropriate actions as [FDA] deems necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or sustaining human life, [FDA] shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.139

The apparent inconsistency between the definition of Class II devices (those for which general controls were insufficient and for which additional controls would be necessary) and the discretionary power of the FDA to promulgate performance standards or use its other powers (epitomized by the use of the word may) was resolved by a legislative compromise. Class II would include devices on which information was sufficient to establish one or more special controls140—but the FDA did not have to adopt any of those controls unless it concluded that it was necessary to provide reasonable assurance of safety and effectiveness.141 That solution alleviated resource burdens on the agency but left open the question of whether the safety and effectiveness of a Class II device could not be ensured if only general controls applied, as the statutory definition seemed to suggest.142

Congress also provided that the FDA could itself initiate a reclassification proceeding and not have to wait for a petition from a manufacturer.143 In addition, the 1990 law simplified the process for issuing performance standards applicable to Class II devices by adopting the usual notice-and-comment rule-making process.144 The FDA could establish other special

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139FFDCA § 513(i)(1), 21 USC § 360c(i)(1) (2006) (as modified by SMDA, § 5(a)(2), 104 Stat. at 4517-18).

140FFDCA § 513(a)(1)(B), 21 USC § 360c(a)(1)(B) (2006).

141FFDCA § 514(a)(1), 21 USC § 360d(a)(1) (2006).

142FFDCA § 513(a)(1)(B), 21 USC § 360c(a)(1)(B) (2006).

143FFDCA § 513(f)(2)(A), 21 USC § 360c(f)(2)(A) (2006) (as modified by SMDA § 5(b), 104 Stat. at 4518).

144FFDCA § 514(b), 21 USC 360d(b) (2006) (as modified by SMDA § 6(a), 104 Stat. at

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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controls through different mechanisms and procedures, some of which are less burdensome than those required for performance standards.

Finally, the revised definition authorizes the FDA to require clinical data as part of 510(k) submissions, resolving another ambiguity in the original 1976 law (Cooper, 1987, p. 192).

Definition of Substantial Equivalence

Congress had not defined substantial equivalence in the 1976 law. By adopting a broad reading of the phrase, set forth in a guidance document in 1986,145 the FDA used the 510(k) system to avoid requiring PMAs for (or alternatively down-classifying) many new and novel devices that would have been placed in Class III.

For instance, the agency allowed a new device to be determined to be substantially equivalent to a preamendment device, notwithstanding important technologic differences, if the new device was as safe and effective as the antecedent. To make that comparison, the FDA could require appropriate comparative data, including clinical studies, from the 510(k) submitter. The guidance is worth quoting at length because it was endorsed by Congress in the 1990 legislative history.

As a matter of practice, CDRH generally considers a device to be SE [substantially equivalent] to a predicate device if, in comparison to the predicate device:

•    the new device has the same intended use…; and,

•    the new device has the same technological characteristics, (i.e., same materials, design, energy source, etc.); or, it has new technological characteristics that could not affect safety or effectiveness; or

•    it has new technological characteristics that could affect safety or effectiveness, and

—there are accepted scientific methods for evaluating whether safety or effectiveness has been adversely affected as a result of the use of new technological characteristics; and

— there are data to demonstrate that the new technological features have not diminished safety or effectiveness.146

*            *            *            *

____________________________________

4519).

145Guidance on the CDRH Premarket Notification Review Program (K86-3) (June 30, 1986) available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081383.htm.

146Id. at 2.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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    [F]rom a scientific perspective, to determine which technological changes are consequential, the Center considers whether:

•    the new device poses the same type of questions147 about safety or effectiveness as a predicate device;

•    there are accepted scientific methods for evaluating whether safety or effectiveness has been adversely affected as a result of the use of new technological characteristics; and

•    there are data to demonstrate that new technological characteristics have not diminished safety or effectiveness.148

The requirements of Section 510(k) of the act are intended not only to notify the FDA that a device is about to be marketed but also primarily to enable the FDA to determine whether the device is substantially equivalent to one already in commercial distribution. To fulfill that responsibility, CDRH requires that a 510(k) submission include descriptive data needed to understand a new device’s intended use, physical composition, method of operation, specifications, performance claims, and other factors. Similar information about the device with which the new device is being compared may also be required. In addition, under some circumstances, the center requires performance-testing information (that is, data from bench, animal, or clinical tests), to determine whether a device performs according to its description.

Although CDRH has concluded that it should sometimes require performance-testing data to confirm that a new device is substantially equivalent, the 510(k) review process is not a substitute for premarket approval, and the center does not attempt to address all the issues that would be answered in a PMA application in its review of 510(k) submissions. Data in a 510(k) submission should show comparability of a new device with a predicate device,149 whereas demonstration, in an absolute sense, of a device’s safety and effectiveness is reserved for PMAs.

The FDA also permitted a postamendment device to claim substantial equivalence to a preamendment device through an implied string of precedents from other postamendment devices previously cleared by 510(k) review, a process known as piggybacking. The guidance stated

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147The guidance gave examples to illustrate that “same type of questions” meant issues raised by both the predicate and the new device and would be answered in the same manner (for example, whether electronic components of electrocardiographs accurately represent the electrical activity of the heart, regardless of whether displayed in an analog visual manner or in digital format).

148Id. at 3.

149Id. at 4.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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The Center does not routinely require that manufacturers perform research to determine what specific predicate devices were available in 1976, or were available at the time a post-Amendments device was reclassified from class III to class I or II; nor does the Center routinely require that all 510(k) s initially provide information on a predicate device. Instead, the Center requires submitters to provide information that compares the new device to a marketed device of a similar type, regardless of whether this marketed device was marketed before or after enactment of the Amendments, or before or after a type of post-Amendments device was reclassified.150

Whether the FDA could lawfully assess comparative safety and effectiveness to determine substantial equivalence, could require clinical studies to demonstrate comparable safety and effectiveness, or could permit piggybacking under the 510(k) law as written in 1976 were controversial issues (Cooper, 1987; OTA, 1984).

By 1989, the agency was sufficiently concerned that an adverse court ruling on its interpretation of substantial equivalence would cripple the 510(k) clearance process, and thus force many new devices into the PMA system, that it sought legislative ratification of its policy.151 In 1990, Congress obliged, adding the following language to the statute:

A. For purposes of determinations of substantial equivalence … the term “substantially equivalent” or “substantial equivalence” means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that [FDA] by order has found that the device –

(i)  has the same technological characteristics as the predicate device, or

(ii) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including clinical data if deemed necessary by [FDA], that demonstrates that the device is as safe and effective as a legally marketed device and (II) does not raise different questions of safety and efficacy than the predicate device.

B.–For purposes of subparagraph (A), the term “different technological characteristics” means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device.152

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150Id. at 2.

151Medical Device Safety: Hearings Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 101st Cong. 172 (1989–1990) (statement of James S. Benson, Acting Commissioner, Food and Drug Administration).

152FFDCA § 513(i)(1), 21 USC § 360c(i)(1) (2006) (added by SMDA § 12, 104 Stat. at 4523).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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The reports of the House and Senate committees responsible for this legislation make clear that the intent was to codify the FDA’s practice.153 Congress understood that the statutory change would permit the agency to consider the safety and effectiveness of a device when determining substantial equivalence154 and added another provision that required a 510(k) sponsor to submit either a summary of “any information respecting safety and effectiveness” (which the FDA would make public within 30 days of finding substantial equivalence) or a statement that such information would be available to any person on request.155 Arguably, those changes represented an effort by Congress and the FDA to redesign the 510(k) system to include an evaluation of safety and effectiveness of all new devices.156 Nevertheless, the statutory scope of such an evaluation was very limited. The standard for substantial equivalence permitted the agency to use safety and effectiveness data only when a new device offered technologic characteristics that differed from those of the predicate device. Moreover, Congress made clear that it did not believe that a substantial-equivalence determination was a finding of safety or effectiveness. The House report states

A determination by the FDA that a device is substantially equivalent to another device is a final agency action under the substantial equivalent provisions, but it does not preclude further agency action regarding safety and effectiveness.157

The new language provided a solid legal basis for the FDA’s 510(k) policies. The agency could incorporate some degree of safety and effectiveness assessments into the 510(k) system because it would now be required to find “by order” that a new device with different technological characteristics was at least as safe and effective as its predicate. To do so, it clearly could require appropriate safety and effectiveness information, including clinical studies when necessary. And piggybacking was automatic because a new product could rely on any lawfully marketed device as a predicate.

Congress had now formally opened the door for safer or more effective medical devices to reach the market via the 510(k) pathway. By being permitted to show that its product was “as safe and effective as” a predicate (instead of merely having substantially equivalent safety and effectiveness), the 510(k) submitter could improve the safety and effectiveness of a type of device without triggering the risk of being found NSE and having to undergo

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153H.R. Rep. No. 101-808, at 25; S. Rep. No. 101-513 at 41.

154Id.

155FFDCA § 513(i)(3), 21 USC § 360c(i)(3) (2006) (added by SMDA § 12, 104 Stat. at 4523).

156As will be discussed below in the section “The Supreme Court Considers the 510(k) Clearance Process,” the FDA and the solicitor general did not make this argument to the Supreme Court in 1996.

157H.R. Rep. No. 101-808, at 25.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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a PMA review. A new device might be both superior to its predicate and substantially equivalent to it. The legislative history noted, “In this way, the standard for safety and effectiveness in a determination of substantial equivalence will evolve slowly as the prevailing level on the market changes, rather than being tied solely to comparison with a pre-1976 device.”158

Congress did not define predicate device but prohibited the use as a predicate of any device removed from the market by the FDA or found by a court to have been adulterated or misbranded.159 Thus, the 1990 amendments did not require reliance on the best available predicate device, so a new product that was truly inferior to the current state of the art might still enter the market—if the manufacturer could identify any predicate that had not been removed from the market and to which it was substantially equivalent. 160 In this regard, the law did not force innovation. Indeed, by that amendment, Congress also made every prior 510(k) decision a precedent binding on the FDA, which had no explicit power to rescind these actions. Only if the FDA banned a marketed device or had a court adjudicate the device as adulterated or misbranded could the device no longer serve as a predicate.

Requirement for Final Food and Drug Administration Action on a 510(k) Submission

Under the MDA, a company had to give the FDA 90 days’ notice before introducing a new product to the market through the submission of a 510(k) notification. If the FDA failed to respond to the filing in the 90-day window, the manufacturer was free to launch the product beginning on the 91st day. Congress eliminated the risk that a product could enter medical use by the FDA’s failure to act by requiring the 510(k) submitter to wait for a written response (called an order) from the FDA stating that its product was substantially equivalent before commercializing it.161

Preamendment Class III Devices

Both the House and the Senate committees considering the 1990 legislation were displeased by the FDA’s lack of progress since 1976 in pro-

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158H.R. Rep. No. 101-808, at 25.

159FFDCA § 513(i)(2), 21 USC § 360c(i)(2) (2006) (added by SMDA § 12, 104 Stat. at 4523).

160In its 1988 bill, the House would have used the standard “as safe and effective as comparable devices which are currently sold in interstate commerce.” H.R. Rep. No. 100-782 at 4 and 23. Arguably, this standard would have been more rigorous than the one finally adopted.

161FFDCA § 513(i)(1)(A), 21 USC § 360c(i)(1)(A) (2006) (added by SMDA § 12, 104 Stat. at 4523).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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mulgating regulations to require PMAs for, and then reviewing the safety and effectiveness of, preamendment Class III devices and devices that had entered the market as substantially equivalent to them.162 In conjunction with revising the definition of Class II, Congress authorized the FDA to reconsider all the preamendment devices that had originally been placed in Class III to reduce the number of device types that needed PMA review.163 The agency was also directed “as promptly as possible” but no later than December 1, 1996, to establish a schedule for promulgation of regulations calling for PMAs of devices not down-classified to Class II that still used the 510(k) pathway to marketing.164

The FDA was not, however, given a deadline by which to complete the PMA process for Class III preamendment devices not reclassified to Class II.

Changes in General (Postmarketing) Controls

Much of the momentum for legislation in 1988–1990 came from reports that the FDA had difficulties in learning about serious problems with marketed devices.165 Thus, many of the provisions in the SMDA of 1990 focused on identifying issues of safety or lack of effectiveness sooner and giving the FDA additional tools to use when problems were encountered. As with the original 1976 law, these controls were applicable under the 1990 amendments without regard to the classification of a device for premarket review purposes.

User Reporting of Device Risks

A GAO study in 1986 revealed that hospitals often did not report potentially hazardous medical devices to the FDA or the manufacturers.166 Even though manufacturers were required to investigate and report to the FDA information received from hospitals, physicians, patients, and others, the system would fail if users did not report to the manufacturers. To address that gap, Congress required “device user facilities”—defined as hospitals, ambulatory surgical facilities, nursing homes, and outpatient treatment facilities (but not physician offices)—to report to the FDA and to the manufacturer when a medical device caused or contributed to the death or serious

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162H.R. Rep. No. 101-808, at 14, 25-26; S. Rep. No. 101-513, at 14-15, 18.

163FFDCA § 515(i), 21 USC § 360e(i) (2006) (added by SMDA § 4(b), 104 Stat. at 4515-17).

164FFDCA § 515(i)(2), 21 USC § 360e(i)(2) (2006).

165H.R. Rep. No. 101-808, at 14; S. Rep. No. 101-513, at 15-16.

166H.R. Rep. No. 101-808, at 14 (citing (gao, 1986)).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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illness of a patient.167 The FDA was directed to promulgate implementing regulations within 12 months.168

Postmarket Surveillance

The FDA was given authority to require the manufacturer of any device initially introduced to commerce after 1990 to develop and conduct a surveillance plan if the device was a permanent implant whose failure might cause death or serious adverse health consequences, was intended to support or sustain human life, potentially presented a serious risk to human health, or was determined by the FDA to need surveillance to provide safety or effectiveness data or to protect public health.169 The statute used the phrase postmarket surveillance to refer specifically and narrowly to these plans and did not include other safety monitoring and vigilance systems in the phrase. It did not specify any particular methods, but only that the protocol “will result in collection of useful data … to provide information necessary to protect the public health and to provide safety and effectiveness information for the device.”170

Device Tracking

For any device whose failure would be reasonably likely to have serious health consequences and that was permanently implantable or was a life-sustaining or life-supporting device used outside a “device user facility,” the manufacturer was required to adopt a method of device tracking (such as a patient registry).171 The purpose of tracking was to maintain a system whereby an individual patient or end user (as well as the relevant physicians) could be notified of new risks and the devices could be recalled if necessary.172

Reports of Removals and Corrections

The 1990 amendments required a device manufacturer to report to the FDA whenever it removed or corrected a device if that was done to reduce a risk to health posed by the device or to remedy a violation of the FFDCA caused by the device that might result in a risk to health.173 (Corrections

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167FFDCA § 519(b), 21 USC § 360i(b) (2006) (added by SMDA § 2, 104 Stat. at 4511-13).

168SMDA § 2(b), 104 Stat. at 4512-13.

169FFDCA § 522, 21 USC § 360l (2006) (added by SMDA § 10, 104 Stat. at 4521-22).

170FFDCA § 522(b), 21 USC § 360l(b) (2006) (added by SMDA § 10, 104 Stat. at 4522).

171FFDCA § 519(e), 21 USC § 360i(e) (2006) (added by SMDA § 3(b), 104 Stat. at 4514).

172H.R. Rep. No. 101-808, at 23.

173FFDCA § 519(f), 21 USC § 360i(f) (2006) (added by SMDA § 7, 107 Stat. at 4520).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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might include, for example, software patches, replacement of parts, or revision of operating instructions or directions for use.) Congress intended the agency to become aware of actions taken by a manufacturer that suggested a potential public-health problem so that the agency could evaluate the device-related problem and the adequacy of the manufacturer’s corrective actions.174

Recall Authority

The FDA had previously relied on voluntary actions by manufacturers to recall devices believed to violate the law. In the event that a manufacturer failed to act, the agency could go to court to seek orders to seize the devices wherever they were found,175 a costly and time-consuming effort in comparison with voluntary recalls. (The 1976 act empowered the FDA only to issue an administrative order detaining devices for up to 20 days to permit the judicial process for a seizure action to be completed.176) The SMDA changed that situation substantially. The FDA could now order manufacturers (and others, including distributors and retailers) immediately to cease distribution of a device, to notify healthcare providers and device-user facilities to cease using the device, and to recall the device if there was a reasonable probability that the device would cause serious adverse health consequences or death.177

Civil Money Penalties

The FFDCA of 1938, as amended by the MDA of 1976, created a limited array of sanctions to penalize individuals and companies that violated the law: criminal fines and imprisonment and seizure and forfeiture of violative products.178 Those penalties could be imposed only after a trial in federal court, criminal punishments required proof beyond a reasonable doubt, and the threat of imprisonment did not apply to corporations. To enhance the FDA’s enforcement credibility, Congress in 1990 provided that the FDA could also impose substantial civil money penalties by an administrative hearing without going to federal court for any violation of the law related to medical devices. The amounts authorized ranged up to $15,000 for each violation and up to $1 million for all violations adjudicated in a single proceeding.179

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174S. Rep. No. 101-513, at 23; H.R. Rep. No. 101-808, at 29.

175FFDCA § 304(a)(2)(D), (b), 21 USC § 334(a)(2)(D), (b) (2006).

176FFDCA § 304(g), 21 USC § 334(g) (2006).

177FFDCA § 518(e), 21 USC § 360h(e) (2006) (added by SMDA § 8, 104 Stat. at 4520-21).

178FFDCA § 303(a), 21 USC § 333(a); § 304(a)–(d), 21 USC § 334(a)–(d) (2006).

179FFDCA § 303(f), 21 USC § 333(f) (2006) (added by SMDA § 17, 104 Stat. at 4526-28).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Design Controls as Part of Good Manufacturing Practices

The 1976 MDA had authorized the FDA to issue regulations requiring that the methods used in and the facilities and controls used for the manufacture, storage, and installation of medical devices conformed to current good manufacturing practices (GMP) to ensure that the devices would be safe and effective and otherwise comply with FDA law.180 The agency wanted to include as a GMP requirement the concept of design validation to require a manufacturer, as a preproduction control, to implement a process to demonstrate that the components of the device (singly or in combination) will perform in a manner consistent with their intended purpose. The FDA estimated that 44% of device recalls in 1983–1988 were related to product design problems. Design validation was already a recognized element of quality control in the European Community. But the FDA and Congress were concerned that the MDA might not provide sufficient authority.181 Accordingly, the 1990 amendments explicitly authorized language that the FDA’s GMP regulations to require that “pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device)” also conform to “current good manufacturing practice.”182

DEVELOPMENTS IN 1990–1997

The Medical Device Amendments of 1992

The 1990 legislation directed the FDA to promulgate final regulations implementing the authority to require adverse–medical-event reporting by user facilities by May 28, 1992; if not, any proposed regulations would automatically become effective.183 The FDA did not issue proposed regulations until March 27, 1992, so that left only 2 months for public comment and for implementation. Congress elected to extend the effective dates by 6 months (for the regulations) and 9 months (for implementation).184

The failure to meet the statutory deadlines for issuance of regulations prompted both a GAO review and a congressional hearing before the House Subcommittee on Health and the Environment. GAO reported that in July 1990, the acting commissioner of the FDA had identified the following six

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180FFDCA § 520(f)(1)(A), 21 USC § 360j(f)(1)(A) (2006).

181H.R. Rep. No. 101-808, at 33.

182FFDCA § 520(f)(1)(A), 21 USC § 360j(f)(1)(A) (2006) (as amended by SMDA § 18(e), 104 Stat. at 4529).

183SMDA § 3(c), 104 Stat. at 4514-15.

1841992 MDA § 2, 106 Stat. at 238.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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factors that contributed to the delay in the rule-making process: (GAO, 1992, p. 7)

•    Emergence of significant problems during the regulations development process that require reevaluation of previous agreements [within the FDA and with HHS and OMB] on regulation content.

•    Competition among priorities within the agency, including with other regulatory and enforcement activities.

•    Required reviews within the FDA, and by [HHS] and OMB.

•    Need to coordinate with other agencies.

•    Uncertainty as to the appropriate scope of review.

•    Lack of resources.

•    At the hearing, the FDA witnesses had testified about steps being undertaken to make the process more efficient.185

The need to extend the deadline provided an opportunity for a number of linguistic and technical corrections and clarifications to be made in other parts of the SMDA of 1990.186 None of them had a material effect on the provisions under discussion.

February 1993 Department of Health and Human Services Inspector General Report

In response to a request from the House Subcommittee on Oversight and Investigations, the HHS inspector general performed a follow-up review regarding the July 1990 report.187 One topic addressed was the Office of the Inspector General’s prior recommendation that the FDA establish “a quality control review system that involves independent review of completed 510(k) decisions by an FDA group … to evaluate and critique the adequacy of reviewed submissions.”188 The inspector general concluded that the steps taken by CDRH since 1990 “primarily focus on the 510(k) administrative process and not the scientific validity of the decisions made by the 510(k) reviewers. Also, quality control reviews of the 510(k) staff were not always documented.”189

The significance of that observation lies in the implicit findings, in both 1990 and 1993, that CDRH lacked a robust quality-assurance program to

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185Food and Drug Administration Oversight: Hearing Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 102d Cong., pt. 2 (1992).

1861992 MDA §§ 3-4, 106 Stat. at 238-39.

187Memorandum from the principal deputy inspector general to the acting assistant secretary for health, Re: Follow-Up Review on Internal Control Weaknesses in the Food and Drug Administration’s Medical Device 510(k) Review Process (Feb. 26. 1993).

188Id. at ii.

189Id. at 19.

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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ensure both consistency and correctness in 510(k) decisions for at least the first 16 years after the MDA’s enactment.

1992–1997 Changes in the Food and Drug Administration Environment Affecting Device Regulation

At least four events had an important effect on device regulation during the 1990s. First, in 1992, FDA Commissioner David Kessler asked a task force drawn largely from the Center for Drug Evaluation and Research (CDER), headed by Robert Temple, to conduct a review of the quality of clinical science submitted to CDRH in support of 510(k) submissions and PMA applications. The resulting report was critical, observing (albeit on the basis of a small sample of PMA applications and 510(k) submissions containing clinical data) that studies submitted in support often failed to meet fundamental scientific standards. For example, the studies did not describe their purposes or the hypotheses to be tested, they failed to consider the value of randomized control groups, and they contained numerous deficiencies in conduct, reporting, and analysis (FDA, 1993). The report recommended a definite but gradual upgrading in the quality of clinical studies to support PMA applications and 510(k) submissions. CDRH undertook to implement the recommendations soon afterward.

In parallel with those changes and the 1990 amendments that explicitly referenced clinical data as an element of 510(k) submissions, the percentage of 510(k) submissions for which the FDA requested clinical data soon rose from 5% to 15% (Merrill, 1994, p. 64).

Commissioner Kessler also pushed the “medicalization” of CDRH. From its inception before the passage of the MDA of 1976, the center’s leadership had expertise in engineering and administration but not in medicine. In 1993, the commissioner appointed the first physician to head CDRH: D. Bruce Burlington, who had previously served in both CDER and the Center for Biologics Evaluation and Review (CBER). Also for the first time, a physician was appointed to head the Office of Device Evaluation. Medical personnel became more common among the device review staff and operations. When Burlington left CDRH in 1999, he was succeeded as permanent director by David Feigal, another physician with experience in both CBER and CDER. Every later permanent CDRH director has been a physician, and medically trained persons have led other key CDRH offices.

The third change in the environment occurred in November 1994, when the Republican Party won control of both houses of Congress. All the medical-device legislation to date had been drafted and enacted when the Democratic Party, which generally had been more inclined to favor government regulation, had been in the majority. Now the FDA legislation, budgets, and activities were to be overseen by a party that was traditionally

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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more skeptical of government regulation and more sympathetic to industry concerns about the claimed direction of device regulation.

Finally, after Congress codified the FDA’s standard for substantial equivalence in the 1990 amendments, the agency broadened the standard even further. As was explained to the IOM committee

According to the statute, in the face of different technologic characteristics, the agency asks whether the differences raise new safety or effectiveness questions. If the answer is yes, the device is found to be not substantially equivalent. The agency has not applied the statutory language exactly but asks whether the new technology raises new types of questions about safety and effectiveness. The reason that that word types was added to the program guidance is that any change in technology can raise a new question. By asking about new types of questions, the agency has greater discretion in making some of its regulatory decisions…. Similarly, when considering whether a product is as safe and as effective as another product, the agency asks whether the risks that are inherent in the new technology can be mitigated. In other words, if the technology and the effect of the change on the actual use of the product are well understood, the agency does not automatically reclassify the device to make it subject to PMA; instead, it looks to mitigate risks. (IOM, 2010, p. 11)

Those interpretations continued the policy of minimizing the number of 510(k) submissions that were rejected.

The Supreme Court Considers the 510(k) Clearance Process

In 1996, the Supreme Court examined the 510(k) clearance process in some depth.190 At issue was whether a civil private lawsuit by a patient against a manufacturer for injuries allegedly resulting from a device was barred by the pre-emption provisions of the 1976 MDA. The law said that a state could not establish a requirement with respect to a device related to safety or effectiveness of the device that was different from or in addition to those requirements imposed by the FDA law.191 In the product liability suit, the manufacturer argued that imposition of liability by a state court based in tort law had the effect of creating such requirements with respect to design of the device. The device in question was a postamendment Class III product cleared through the 510(k) clearance process. The Court therefore had to assess the legal effect of the 510(k) review to determine whether it did create such requirements.

Although the FDA was not a party to the suit, the US solicitor general

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190Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

191FFDCA § 521(a), 21 USC § 360k(a) (2006).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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filed a brief against pre-emption that explained the federal government’s official view of the 510(k) clearance process192:

The clearance of a post-Amendments device under Section 510(k)—based on a determination that the device is substantially equivalent to a pre-Amendments Class III device—does not reflect a determination by the FDA that the device is safe and effective, much less a specific determination that the device’s design is required to ensure its safety and effectiveness. “[A] determination of substantial equivalence … is not equivalent to an approval by the FDA of the device’s safety and effectiveness.” H.R. Rep. No. 808 [101st Cong., 2d Sess. (1990)], at 14 … As the court of appeals observed, the FDA ordinarily will not have determined whether the pre-Amendments device was safe and effective (since the FDA lacked the general authority to do so prior to enactment of the Amendments)…. Accordingly, FDA regulations specify that a substantial equivalence determination “does not in any way denote official approval of the device,” and that any representation conveying “an impression of official approval … is misleading and constitutes misbranding.”

In its opinion, the Court contrasted the “rigorous PMA review” with the 510(k) clearance process and found them “by no means comparable.” Going beyond the argument of the solicitor general, the Court observed that,193

in contrast to the 1,200 hours necessary to complete a PMA review, the § 510(k) review is completed in an average of only 20 hours…. As one commentator noted: “The attraction of substantial equivalence to manufacturers is clear. [Section] 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed very quickly.”

Turning to the specific argument of the manufacturer, the majority opinion of the Court stated194:

As the court below noted, “[t]he 510(k) process is focused on equivalence, not safety.” … As a result, “substantial equivalence determinations provide little protection to the public. These determinations simply compare a post-1976 device to a pre-1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.” …

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192Brief for the United States as Amicus Curiae Supporting Respondents/Cross-Petitioners 19-20, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (No. 95-754) (some internal citations omitted).

193Lohr, 518 U.S. at 478-79 (citations omitted).

194Id. at 493–494 (internal citations omitted).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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There is no suggestion in either the statutory scheme or the legislative history that the § 510(k) exemption process was intended to do anything other than maintain the status quo with respect to the marketing of existing medical devices and their substantial equivalents.

An opinion, representing the views of all the other justices, concurred that the 510(k) “process merely evaluates whether the Class III device at issue is substantially equivalent” to a preamendment device.195

In sum, the Supreme Court found that the 510(k) clearance process did not provide a rigorous review for safety and effectiveness of a device but only determined the new device’s comparability with a predicate device, which itself may never have been assessed for safety or effectiveness. Thus, it established no design requirements that would conflict with and therefore pre-empt state law.

The Supreme Court revisited the pre-emptive effects of the MDA. In 2001, the Court considered whether a fraud on the agency could be a basis for liability under state law or instead was pre-empted because it would interfere with federal prerogatives to protect the agency’s own processes. A threshold issue in the case was whether a 510(k) submission that contained untrue statements could be material fraud on the FDA. The Court held that it did, but it did not appear to change its view of the limited role of the 510(k) as a premarket clearance process196:

Admittedly, the § 510(k) process lacks the PMA review’s rigor: The former requires only a showing of substantial equivalence to a predicate device, while the latter involves a time-consuming inquiry into the risks and efficacy of each device. Nevertheless, to achieve its limited purpose, the § 510(k) process imposes upon applicants a variety of requirements that are designed to enable the FDA to make its statutorily required judgment as to whether the device qualifies under this exception.

In 2008, the Court revisited the issue of pre-emption of liability claims by injured patients based on theories of design defects, failure to test, and lack of adequate warnings. In this case, however, the device was a Class III device that had undergone full PMA review and approval. The Court relied on its 1996 analysis comparing the “limited review” in the 510(k) clearance process with the “rigorous” PMA review; the latter imposed numerous and specific requirements on the design, testing, labeling, and other aspects of the manufacture, modification, and distribution of the approved device. Under those circumstances, the Court held that because state tort law could impose requirements related to the safety and effectiveness of the device different

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195Id. at 513.

196Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348–349 (2001).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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from or in addition to those imposed by the PMA process under the MDA, the state law would be pre-empted.197

January 1997 General Accounting Office Report

GAO undertook an extended examination of the FDA’s adverse–medical-event reporting system in light of the changes directed by the SMDA of 1990 (GAO, 1997a). It concluded:

Although the amount of information reported to FDA about medical device problems has increased dramatically since SMDA 90 was enacted, FDA does not systematically act to ensure that the reported problems receive prompt attention and appropriate resolution. As a result, FDA’s adverse event reporting system is not providing an early warning about problem medical devices as SMDA 90 intended. (GAO, 1997a, p. 2)

GAO observed a long-term increase in the number of reports received by the FDA: the “increased volume made it difficult for FDA to process and review reports in a timely manner” (GAO, 1997a, p. 3). In addition, the FDA was not routinely documenting any corrective actions it (or manufacturers) took to address reported problems (GAO, 1997a, p. 3). Although GAO did not make any recommendations, it did recite a number of steps that the FDA was already taking to improve its system.

THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997

A variety of bills addressing congressional concerns about FDA regulation of foods, drugs, and medical devices were consolidated and passed as the FDA Modernization Act of 1997.198 The device-related provisions modified both premarket and postmarket controls generally in the direction of restricting the FDA’s preclearance authorities to accelerate the pace of technology transfer.

Modifications Regarding Premarket Review of Devices

Congress concluded that the FDA regulatory system was not keeping pace with medical innovation. “In a number of cases, for both 510(k)-cleared and PMA products, increased requirements that are burdensome, expensive, and time-consuming have delayed patients’ access to promis-

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197Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008).

198Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (1997) [hereinafter FDAMA]).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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ing new devices.”199 Furthermore, the total number of days for reviewing both 510(k) and PMA applications remained well above what Congress demanded in existing law. For example, the FDA averaged 110 days in FY 1996 to review a 510(k), down from a high of 184 days in FY 1994 but still higher than the 90 days called for in the statute. 200 For PMAs, the average review time in FY 1996 was 572 days, down from a high of 649 in FY 1994 but also higher than the statuatory 180-day limit.201 Many of the changes made in 1997 were designed to reduce the FDA’s workload and permit concentration of resources on devices that presented greater potential for harm. Some also reflected a concern that the changes in CDRH resulting from the Temple report and the infusion of medical personnel into senior CDRH management had led to an undue emphasis on clinical-trial data to support PMA applications and 510(k) submissions. The overall thrust of the 1997 amendments was to limit the FDA’s discretion and authority in regulating the device industry.

Elimination of 510(k) Requirements for Most Class I and Some Class II Devices

Congress exempted from 510(k) notification requirements all Class I devices except for those “intended for a use which is of substantial importance in preventing impairment of human health” or “present[ing] a potential unreasonable risk of illness or injury.”202

The new law also directed the FDA (within 60 days of enactment) to identify each type of device in Class II for which a 510(k) submission would not be necessary to provide reasonable assurance of safety and effectiveness. Those identified would be exempt from 510(k) requirements as soon as the FDA announced its decision to exempt them.203 In addition, the FDA was authorized to exempt additional types of Class II devices from 510(k) submission in the future on the initiative of the agency or on petition by an interested person.204

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199H.R. Rep. No. 105-307, at 13 (1997).

200The number of review days is not the same as the number of days invested in reviewing a submission. The former is a calculation of the number of days between receipt of a submission and when it is finally acted on, omitting the number of days that FDA is waiting for responses to questions from the person making the submission. The latter looks only at the time that FDA employees are engaged in the review of the submission.

201Id. at 14.

202FFDCA § 510(l), 21 USC § 360(l) (2006) (added by FDAMA, § 206(a), 111 Stat. 2338-39 (1997).

203FFDCA § 510(m)(1), 21 USC § 360(m)(1) (2006) (added by FDAMA § 206(a), 111 Stat. at 2338-39).

204FFDCA § 510(m)(2), 21 USC § 369(m)(2) (2006) (added by FDAMA § 206(a), 111 Stat. at 2338-39).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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The results of that change could be described as creating a class of devices (mostly in Class I and some in Class II) for which no preclearance is required, confirming a large subset of Class II for devices that would not be subject to any special control (that is, requiring only a 510(k) review showing substantial equivalence to a predicate device, as was the case for Class I devices under the 1976 MDA), and establishing another subset of Class II devices more akin to the original 1976 vision of Class II that combined 510(k) preclearance with one or more of the special controls envisioned by the 1976 and 1990 amendments. Thus, Class II had become divided, for practical purposes, into three groups: “Class IIA” (no preclearance and no special controls required; that is, effectively Class I), “Class IIB” (preclearance required but without special controls), and “Class IIC” (both preclearance and controls required). Given that the FDA had issued few special controls on Class II devices, the decision to exempt some Class II devices even from 510(k) notification requirements raises the question whether these devices should ever have been in Class II.

Authorization of Third-Party Review of 510(k) Submissions for Other Class I and Class II Devices

Congress directed the FDA to establish a scheme whereby third parties could be accredited to perform 510(k) reviews for any Class I or Class II device for which a 510(k) submission was still required other than Class II devices intended to be permanently implantable or life-sustaining or life-supporting or for which clinical data are required.205

Evaluation of Automatic Class III Designations

The new law required the FDA to evaluate whether a new device that, after submission of a 510(k) notification by the sponsor, was determined to be NSE to another device and therefore was automatically placed in Class III could be classified into Class I or Class II immediately without having to undergo PMA review.206 That process, now called the de novo 510(k), would be triggered by a request from the 510(k) submitter and have to be completed within 60 days. In the de novo process, the issue presented to the FDA is simply whether the device meets the criteria for Class I or Class II, in which case it is classified as a new device and becomes a predicate to which later devices may refer.

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205FFDCA § 523, 21 USC § 360m (2006) (added by FDAMA § 210, 111 Stat. at 2342-45).

206FFDCA § 513(f)(2), 21 USC § 360c(f)(2) (2006) (added by FDAMA § 207, 111 Stat. at 2340).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Limitation of Food and Drug Administration Authority to Withhold 510(k) Clearance Because of Failure to Comply with Other FFDCA Requirements

Congress understood that the FDA had undertaken a policy of withholding clearance of a 510(k) submission when an inspection of the manufacturer revealed GMP violations. To countermand that use of FDA authority, the 1997 law required the agency to act on the 510(k) submission without regard to the manufacturer’s failure to comply with any other provision of the FFDCA “unrelated to a substantial equivalence decision.” To be clear, Congress went on to say that “including a finding that the facility in which the device is manufactured is not in compliance with good manufacturing requirements … (other than a finding that there is a substantial likelihood that the failure to comply … will potentially present a serious risk to human health).”207

Restriction of Scope of Review to Proposed Indications for Use

In response to complaints that the agency was denying 510(k) clearances because of potential “off-label” uses, Congress specified that the FDA was to make determinations solely on the indications for use proposed by the manufacturer in the labeling with the 510(k) submission.208 The new law did, however, permit the agency to require warnings in labeling with respect to off-label uses if there is a reasonable likelihood that the device will be used for an intended use not identified in the proposed labeling and that use could cause harm. That special authority could be exercised only by the director of the Office of Device Evaluation, not by any subordinate managers.

Restriction of Scope of Review to Least Burdensome Means of Demonstrating Equivalence

The SMDA of 1990 had codified the FDA’s approach to determining substantial equivalence, including authorizing the FDA to request additional information in the 510(k) submission to confirm equivalence.209 The FDA had already, on its own initiative, revised the substantial-equivalence standard to limit requests for data only when the differences presented new

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207FFDCA § 513(f)(5), 21 USC § 360c(f)(5) (2006) (added by FDAMA § 206(b), 111 Stat. at 2339).

208FFDCA § 513(i)(1)(E), 21 USC § 360e(i)(1)(E) (2006) (added by FDAMA § 205(b), 111 Stat. at 2337-38).

209FFDCA § 513(i)(1)(A)(ii), 21 USC § 360c(i)(1)(A)(ii) (2006) (“the information submitted that the device is substantially equivalent to such other device, including clinical data if required by [FDA], demonstrates that the device is as safe and effective as such other device which is currently being sold”).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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types of questions or new risks that could not be mitigated (IOM, 2010, p. 11). In 1997, Congress restricted the agency further, specifying that the FDA could request information only if it were necessary to make the substantial-equivalence determination. Moreover, in making such a request, the FDA has to “consider the least burdensome means of demonstrating substantial equivalence and request information accordingly.”210

Device Classification (and Reduction in Scope of PMA Review Regarding Effectiveness) to Consider Substitution of Postmarket Controls

The 1997 law directed the FDA to “consider the extent to which reliance on postmarket controls may expedite the classification of devices” into Class I or Class II instead of Class III.211

Congress ordered that “in making a determination of a reasonable assurance of effectiveness” in reviewing a PMA, the FDA must “consider whether the extent of data that otherwise would be required for approval … with respect to effectiveness can be reduced through reliance on postmarket controls.”212

The legislation also provided for collaborative determinations by the FDA and a PMA applicant of the type of scientific evidence needed to approve a particular PMA. The law created a process for meetings, internal appeals of scientific disagreements between a company and the FDA reviewers, and binding written FDA commitments on the evidence needed.213 Congress was again interested in reducing unnecessary clinical testing of medical devices. It provided214:

Any clinical data, including one or more well-controlled investigations, specified in writing by [FDA] for demonstrating a reasonable assurance of device effectiveness shall be specified as [a] result of a determination by [FDA] that such data are necessary to establish device effectiveness. [FDA] shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.

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210FFDCA § 513(i)(1)(D), 21 USC § 360c(i)(1)(D) (2006) (added by FDAMA § 205(b), 111 Stat. at 2337).

211FFDCA § 513(i)(C), 21 USC § 360c(i)(C) (2006) (added by FDAMA § 205(b), 111 Stat. at 2337).

212FFDCA § 513(a)(3)(C), 21 USC § 360c(a)(3)(C) (2006) (added by FDAMA § 205(a), 111 Stat. at 2336).

213FFDCA § 513(a)(3)(D), 21 USC § 360c(a)(3)(D) (2006) (added by FDAMA § 205(a), 111 Stat. at 2336-37); FFDCA § 562, 21 USC § 360bbb-1 (2006) (added by FDAMA § 404, 111 Stat. at 2368).

214FFDCA § 513(a)(3)(D)(ii), 21 USC § 360c(a)(3)(D)(ii) (2006) (added by FDAMA § 205(a), 111 Stat. at 2337).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
×

Finally, the new law clarified that establishing effectiveness would require only one clinical investigation.215 The legislative history of these provisions contains the following explanation, which underscores the negative congressional reaction to the Temple report of 1993, which had recommended greater consideration of randomized controlled studies to support medical-device safety and effectiveness216:

The Committee believes that [these amendments] are necessary to and consistent with improving communication between the FDA and regulated persons, increasing regulatory efficiency, and decreasing the length of product review and approval. In particular, the Committee is aware of examples where the FDA has requested inappropriate types of clinical testing for certain breakthrough devices and is concerned about instances in which the agency has required sponsors to conduct unnecessary randomized clinical studies to demonstrate device effectiveness. Although randomized clinical testing may be the best means of demonstrating device effectiveness for some products, the Committee is informed that such testing is often unnecessary to demonstrate effectiveness for many devices.

Alternative Procedures for Setting Performance Standards for Class II Devices

The 1997 law provided that the FDA could recognize an appropriate performance standard established by a nationally or internationally recognized organization engaged in standard development. In lieu of an extended notice-and-comment rule-making, the FDA could simply issue a notice of recognition.217 In addition, Congress provided a simplified process for applicants to certify compliance with the standard.218

Priority PMA Review for Important New Devices

Congress directed the FDA to provide review priority for medical devices that represented breakthrough technologies, for which no approved alternatives existed, that offered substantial advantages over existing ap

____________

215FFDCA § 513(a)(3)(A), 21 USC § 360c(a)(3)(A) (2006) (revised by FDAMA § 217, 111 Stat. at 2350).

216H.R. Rep. No. 105-307, at 24 (1997).

217FFDCA § 514(c)(1)(A), 21 USC § 360d(c)(1)(A) (2006) (added by FDAMA § 204(a), 111 Stat. at 2335-36).

218FFDCA § 514(c)(1)(B), 21 USC § 360d(c)(1)(B) (2006) (added by FDAMA § 204(a), 111 Stat. at 2335-36).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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proved alternatives, or whose availability would be in the best interest of patients.219

Certainty of Review Timeframes

Congress reinforced the requirement that 510(k) submissions be acted on within 90 days of filing.220

Modifications of Postmarketing Controls

For the first time, Congress substantially aligned postmarket controls to device classifications in 1997. Perhaps unwittingly, that restructuring may have discouraged the FDA from down-classifying device types from Class II to Class I. Doing so would have sharply reduced the potential regulatory tools available to the agency in the future if a problem with the down-classified type of device emerged.

Limiting Device Tracking to Class II and Class III Devices

The 1997 law limited the FDA’s authority to require device tracking to Class II or Class III devices whose failure would be reasonably likely to have serious adverse health consequences or that are intended to be implanted for more than 1 year or are life-sustaining or life-supporting and used outside a device-user facility.221

Limiting Postmarket Surveillance Requirements to Class II and Class III Devices

Congress also restricted the FDA’s power to order postmarket surveillance for devices to those in Class II or Class III whose failure would be reasonably likely to have serious adverse health consequences or that are intended to be implanted for more than 1 year or are life-sustaining or life-supporting and used outside a device-user facility.222

____________

219FFDCA § 515(d)(5), 21 USC § 360e(d)(5) (2006) (added by FDAMA § 202, 111 Stat. at 2334).

220FFDCA § 510(n), 21 USC § 360(n) (2006) (added by FDAMA § 209(a), 111 Stat. at 2341).

221FFDCA § 519(e), 21 USC § 360i(e) (2006) (revised by FDAMA § 211, 111 Stat. at 2345-46).

222FFDCA § 522, 21 USC § 360l (2006) (revised by § 212, 111 Stat. at 2346).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Changes in Requirements for Reporting Adverse Events Associated with Medical Devices

The 1997 law eliminated mandatory reporting by distributors of medical devices.223 It also eased reporting requirements for device-user facilities and directed the FDA to establish a sentinel reporting system, relying on a representative sample of all device-user facilities, to collect information on device-related deaths and serious illness or injuries.224

1997–2009 DEVELOPMENTS

The Medical Device User Fee and Modernization Act of 2002

The Medical Device User Fee and Modernization Act had two major components but did not make any fundamental change in the general regulatory scheme created by the prior enactments. The first established a “user-fee” program whereby medical-device manufacturers paid fees for some applications, reports, and supplements sent to the FDA for evaluation and imposed performance goals for the FDA in reviewing these applications. The user-fee program was to operate for 5 years. “The fees are based on the relative level of effort required for reviews.”225 It is interesting to observe, therefore, that Congress fixed the effort required for a 510(k) review at 1.75% of that for a PMA review.226 That ratio is not substantially different from the one described by the FDA in 1987, when the agency said that the average PMA review took 1,200 hours but the average 510(k) review took only 20 hours (1.67%).227 Congress also authorized specific federal appropriations for the FDA to conduct safety surveillance of marketed medical devices.

The other part of the legislation consisted of targeted changes to reduce regulatory burdens and agency workload. For example, Congress

•    Created a system whereby people other than federal employees could be accredited to conduct inspections of manufacturers of Class II and Class III devices.228

•    Permitted labeling for prescription devices intended for use in health-

____________

223FFDCA § 519(a), 21 USC § 360i(a) (2006) (revised by FDAMA § 213(a), 111 Stat. at 2346-47).

224FFDCA § 519(b), 21 USC § 360i(b) (2006) (revised by FDAMA § 213(c), 111 Stat. at 2347-48).

225H.R. Rep. No. 107-728, pt. 1, at 24 (2002).

226Id. at 24 table l.1.

227S. Rep. No. 101-513, at 15; Medical Devices and Drug Issues: Hearings Before the Subcomm. on Health and the Env’t of the H. Comm. on Energy and Commerce, 100th Cong. 384 (1987).

228FFDCA § 704(f)–(g), 21 USC § 374(f) (2006) (added by the Medical Device User Fee and

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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     care facilities to be provided solely by electronic means (for example, over the Internet).229

•    Directed that registration of device manufacturers and listing of marketed devices be converted to electronic filings as soon as feasible.230

•    Required the FDA to undertake “modular review” of discrete portions of a PMA before the filing of a complete PMA so that questions on these portions could be resolved early and the number of issues that might delay final approval could be reduced.231

The Medical Devices Technical Corrections Act of 2004

The Medical Devices Technical Corrections Act of 2004 made a series of minor corrections in elements of the 2002 law but did not modify the substance of that act or the overall system for regulating medical devices.232

The Medical Device User Fee Stabilization Act of 2005

The Medical Device User Fee Stabilization Act of 2005 was intended to address gaps in expected revenues in the 2002 user-fee legislation.233

The Food and Drug Administration Amendments Act of 2007

The most recent device-related legislation renewed the user-fee system but did not alter the regulatory scheme in any meaningful way.234

January 2009 Government Accountability Office Report

The 2007 amendments directed GAO to examine which premarket review process—510(k) or PMA—the FDA used to review selected types of devices from FY 2003 through FY 2007.235 It found that the agency had reviewed 13,199 submissions for Class I and Class II devices through the

____________________________________

Modernization Act of 2002, Pub. L. No. 107-250, § 201, 116 Stat. 1588, 1602-09 (2002) [hereinafter, MDUFMA]).

229FFDCA § 502(f), 21 USC § 352(f) (2006) (added by MDUFMA § 206, 116 Stat. at 1613).

230FFDCA § 510(p), 21 USC § 360(p) (2006) (added by MDUFMA § 207, 116 Stat. at 1613).

231FFDCA § 515(c)(3), 21 USC § 360e(c)(3) (2006) (added by MDUFMA § 209, 116 Stat. at 1613).

232Medical Devices Technical Corrections Act, Pub. L. No. 108-214, 118 Stat. 572 (2004).

233Medical Device User Fee Stabilization Act of 2005, Pub. L. No. 109-43, 119 Stat. 439 (2005).

234Medical Device User Fee Amendments of 2007, Title II of the Food and Drug Administration Amendments Act, Pub. L. No. 110-85, 121 Stat. 823, 842 (2007).

235Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85 § 225, 121 Stat. 823, 854 (2007).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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510(k) clearance process and cleared 90% for marketing. In addition, 342 submissions under 510(k) were for Class III devices, of which 67% were cleared. Finally, 217 original PMA applications and 784 supplemental PMA applications for Class III devices had been reviewed, of which 78% were approved. As of October 2008, 20 types of Class III devices could still be cleared through the 510(k) clearance process (GAO, 2009b, pp. 6, 17).236 GAO observed that, relative to the PMA process, the 510(k) review system is generally less stringent, faster, and less expensive. With respect to stringency, GAO said:

For most 510(k) submissions, clinical data are not required and substantial equivalence will normally be determined based on comparative device descriptions, including performance data. In contrast, in order to meet the PMA approval requirement of providing reasonable assurance that a new device is safe and effective, most original PMAs and some PMA supplements require clinical data. In addition, other aspects of FDA’s premarket review are [also] less stringent…. For example, FDA generally does not inspect manufacturing establishments as part of the 510(k) premarket review process—the 510(k) review process focuses primarily on the end product of the manufacturing process rather than the manufacturing process itself. In contrast, the agency does inspect manufacturing establishment as part of its review of original PMA submissions [Footnotes omitted]. (GAO, 2009b, pp. 14–15)

The estimated average cost to the FDA for reviewing a 510(k) in FY 2005 was about $18,200, compared with $870,000 for a PMA (GAO, 2009b, pp. 14–15). That is a ratio of roughly 2.09%, not far from the 1987 ratio of 1.67% based on the estimated numbers of staff-hours to review a 510(k) (20) and a PMA (1,200). As mentioned before, the FDA does not believe that the 1987 estimates are reliable today (Desjardins, 2011).

October 2009 Department of Health and Human Services Inspector General Report

The HHS inspector general conducted a review of medical-device adverse-event reporting in 2003–2007 to assess the extent of reporting, the extent of compliance with reporting requirements by manufacturers and user facilities, and the use of these reports by the FDA to identify and address safety concerns (OIG, 2009). Among the findings, the FDA received twice as many reports in 2007 as in 2003; most manufacturer reports were on time, but many of the user-facility reports and those from manufacturers that were supposed to be filed in 5 days because of their seriousness were

____________

236The FDA reports that as of 2009, 26 types of Class III devices could still be cleared through the 510(k) clearance process (FDA, 2011).

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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late; and CDRH was not using the reports in a systematic manner to identify and address safety issues (OIG, 2009, ii). On the last point, the inspector general made a number of specific observations, which echoed the GAO report of 1997 (OIG, 2009, pp. ii–iii):

•    Analysts did not adequately document information regarding their reviews, so it was difficult to trace a response to an individual event.

•    The FDA could not link postmarket surveillance activities to particular events.

•    The agency lacked a system to document when adverse-event reports resulted in onsite inspections.

•    There was a serious delay between receipt of reports and when they are substantively reviewed in the FDA.

•    The FDA rarely acted when manufacturers or user facilities submitted late reports.

•    The agency made little use of annual reports from user facilities.

The inspector general recommended that the FDA develop a protocol for reviewing adverse-event reports, including documentation requirements, provisions for timely review of high-priority reports, and follow-up with late reporters (OIG, 2009, pp. iii–iv).

CLOSING OBSERVATIONS

This chronologic inventory has attempted to identify materials bearing on six issues relevant to the consideration of the effectiveness of the 510(k) system:

•    Whether a 510(k) determination that a new device is substantially equivalent to a predicate device is a finding that the new device is safe and effective.

•    Whether 510(k) decisions made over the past 35 years are of sufficient quality and reliability to serve as predicates for future 510(k) actions.

•    Whether each type of Class II device must be subject to special controls to provide reasonable assurance of the safety and effectiveness of devices of that type.

•    Whether procedural requirements have unduly interfered with the FDA’s ability to execute its duties.

•    Whether the postmarketing system for detecting device-related adverse medical events or failures of effectiveness can be relied on in

Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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     drawing conclusions about the overall effectiveness of the regulatory scheme.

•    Whether the appropriate balance has been found between premarket clearance and postmarketing controls.

Those issues have repeatedly been identified and discussed by congressional bodies, by HHS, by the courts, and by the FDA itself. The committee’s conclusions and recommendations on those questions are set forth in Chapter 7 of the present report.

As a general observation, however, it is clear that the consistent lack of adequate resources can undo much of what Congress envisions when it enacts a regulatory law. The experience of the FDA in implementing the medical-device law is an excellent example. Congress set forth an elaborate regulatory scheme with classification of all devices, PMA for novel and high-risk devices, performance standards and special controls for medium-risk devices, a preclearance mechanism for medium-risk and low-risk devices, surveillance for adverse events related to devices in use, and numerous powers by which the FDA could act to address problems with marketed devices. Congress never, however, provided the funds to perform all those tasks in strict accordance with the statute and within the timeframes that Congress desired. The agency later concluded that reviewing PMAs and reclassifying Class III devices were too expensive, as would establishing performance standards have been. The FDA evolved the 510(k) mechanism into an alternative to those options.

The system that the FDA operates today reflects cumulative administrative interpretations of the laws enacted by Congress in 1976, 1990, and 1997, informed by internal and external criticisms, advanced by technologic processes, and adjusted to the political and budget priorities of 6 presidential administrations and 18 Congresses. But it is not necessarily the system that would be designed if Congress started over today in recognition of the likelihood of the FDA’s resources for the foreseeable future.

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_______. 2010. CDRH preliminary internal evaluations—Volume I: 510(k) working group preliminary report and recommendations. Silver Spring, MD: Food and Drug Administration.

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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Suggested Citation:"Appendix A: History of Medical-Device Legislation and Regulation in the United States." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150.
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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market.

At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

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