Medical Devices and the Public's Health The FDA 510(k) Clearance Process at 35 Years (2011) / Chapter Skim
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4 The 510(k) Clearance Process
4 The 510(k) Clearance Process
Pages 85-122
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pathway, 1% through PMA, and 1% through programs such as the humanitarian device exemption. The remaining 67% of device types were exempt from premarket review (Class I devices made up 95% and Class II devices 5% of these)
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The 510(k) clearance mechanism rests on the notion of "substantial equivalence." A device must be found to be substantially equivalent to a predicate device if it is to be cleared through the 510(k)
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many new and novel devices that would have been placed in Class III (Hutt et al., 2007, supra note 11, 986) .8,9,10,11,12 Congress had not defined substantial equivalence in the 1976 law.
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. 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 [the FDA]
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Thus, a new device might be superior to its predicate and still be substantially equivalent to it. "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 pre1976 device."16 In contrast, the change did not require reliance on the best predicate device, so a product that was truly inferior to the current state of the art could 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.
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The 510(k) summary must provide sufficient detail to understand the basis for a determination of substantial equivalence (FDA, 2010e)
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Finding 4-1 The 510(k) process determines only the substantial equivalence of a new device to a previously cleared device, not the new device's safety and effectiveness or whether it is innovative.
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It is important 20In January 2011, CDRH announced that it no longer intends to use the term split predicate. It plans to issue guidance to clarify the circumstances under which it is appropriate to use multiple predicates to demonstrate substantial equivalence (FDA, 2011a)
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. As stated above, intended use is one of the legal standards that the FDA is required to adhere to in making a determination about substantial equivalence.
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In the FDA's view, approved labeling content was "authoritative," not "definitive." For medical devices, "indications for use" provides a description of the patient population and disease or condition that the device will diagnose, treat for, prevent, cure, or mitigate.27 The indications for use are meant to represent a relatively precise description of the clinical applications of the device. Indications for use may be derived from clinical studies, may originate from the history of the predicate-device use, or may be defined by the manufacturer.
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Device types that are general tools can often be used for multiple clinical purposes, in multiple clinical disorders, and in multiple anatomic locations.
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Finding 4-4 The 510(k) clearance process does not consistently recognize distinctions among devices cleared solely as tools, those cleared for specific clinical applications, and general tools that also have specific clinical applications.
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Rarely does FDA regulation impinge a physician's freedom to use a device as he or she deems appropriate in the scope of medical practice.29 The scope of the FDA's power to regulate medical practice, traditionally a matter of state regulation, has been a sensitive issue dating back to the legislative debate about passage of the Federal Food, Drug, and Cosmetic Act in 1938.30 Then and when passing the 1962 Drug Amendments, Congress disclaimed an intent of the FDA's regulation of medical products to entail broad regulation of medical practice.31,32 However, courts have never found constitutional limits on the FDA's power to regulate physicians,33 and most legal scholars agree that "there is little doubt under modern law that Congress has ample power to regulate the manufacture, distribution, and use of drugs and medical devices."34 The 1976 Medical Device Amendments expressly authorized the FDA to approve medical devices subject to restrictions on their use and 2921 USC § 396 30See Joel E Hoffman, Administrative Procedures of the Food and Drug Administration, in 2 Fundamentals of Law and Regulation: An In-Depth Look at Therapeutic Products 12, 17-24 (David G
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submissions to avoid a more intensive PMA review is an area of concern. CDRH cited examples in which there has been reasonable 35Medical Device Amendments of 1976, Pub.
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-cleared devices; in the absence of data, there is no basis for concluding whether such uses are, on balance, beneficial or harmful to the public. Finding 4-5 There are no reliable tools for collecting data on the clinical use of and health outcomes related to devices cleared by
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submissions showing substantial equivalence to preamendment devices.39 Congress has directed the FDA several times to finish the transition (FDA, 2011b) .40 Although the FDA has done so for many Class III device types, there are still 25 device types that remain eligible to enter the market through the 510(k)
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submission, as its name implies, is focused on reducing the length and complexity of a submission by allowing an applicant to show that its product conforms with agency guidance documents, special controls, or recognized performance standards as a means of showing substantial equivalence (FDA, 2010a)
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submission is used only where device-specific guidance documents are applicable. Those documents communicate regulatory and scientific expectations both to FDA review staff and to industry.
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submission is based on the premise that the rigorous application of design controls in addition to other 510(k) content requirements can be used to substitute for the traditional determination of substantial equivalence of legally marketed devices that are undergoing substantial modification and require new 510(k)
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The primary mechanisms that the FDA has for communicating with manufacturers the evidentiary requirements needed to support a claim of substantial equivalence in 510(k) submissions are guidance documents and standards.
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In some cases, guidance documents include information on technical specifications, minimal engineering descriptions, and bench-level descriptions that would be sufficient to establish substantial equivalence. In other cases, they provide more extensive information on clinical studies that may need to be conducted to demonstrate substantial equivalence.
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106 TABLE 4-1 FDA Review Time by Availability of Guidance 31–90 Days, 91–365 Days, >365 Days, ≤30 Days, Guidance Mean FDA Days % Completed % Completed % Completed % Completed All, % Completed Available (Mean Total Days) (Number)
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. Effect of Guidance Documents and Standards on Review Time Although it is generally believed that use of guidance documents and standards simplifies the regulatory process, it is not clear how much effect they have on premarket review time (see Table 4-1)
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Device trials are generally designated as either pilot or pivotal, and the specific clinical-trial attributes associated with each of these designations are not standardized or specified. Some guidance documents focus entirely on preclinical device attributes, and others contain little guidance on clinical testing.
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A new submission that has simple and obvious links to a predicate, that has a moderate risk profile, or that has a well-established history of device review may be assigned to a single member of the review staff, who will evaluate it and make a recommendation regarding substantial equivalence to the identified predicate. If unique software, statistical, or clinical issues are raised in the course of the review, consultations with software engineers, statisticians, or physicians may be sought.
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The new information can be used only to assess the submission's claim of substantial equivalence to the predicate(s)
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. CDRH staff reported that they were unable to schedule and hold meetings, or respond to sponsors' requests for information, because of the focus on submission review times (GAO, 2009a)
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submissions are skewing the response times and increase review cycles, but without a detailed file review it is not possible for the present committee to determine whether this is the case. Design Controls The committee was given findings of two studies of the FDA's recall database (IOM, 2011)
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. Manufacturers are required to have design and development controls for all Class II and Class III devices and for several types of Class I devices: any device automated with software, catheters for tracheobronchial suction, surgical gloves, protective restraints, a manual radionuclide applicator system, and a teletherapy radionuclide source.
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This collection of documents forms what is referred to as the device history record and forms a portion of a larger device master record. The master record describes the life of the device through design iterations, modifications, as well as other documents, and it should contain all relevant information about the design of the device.
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As discussed above, given that the FDA has relatively narrow mechanisms for addressing off-label use even when substantial risks are identified, it is often in the position of having to make decisions about substantial equivalence without complete information about how the device will be used once it is cleared. DE NOVO PREMARKET REVIEW The classification system introduced in the Medical Device Amendments of 1976 had provisions that designated all new medical devices that were introduced into the medical marketplace without predicates as Class III devices on the basis of their novelty regardless of risk.
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49 to provide a new mechanism to reclassify statutorily classified Class III devices. The new mechanism, referred to as the Evaluation of Automatic Class III designation (also called de novo or riskbased classification)
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. The FDA found that the average review time for in vitro diagnostic devices going through the de novo process increased from 261 days in 2005 to 448 days in 2009 (see Figure 4-5)
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process determines only the substantial F equivalence of a new device to a previously cleared device, not the new device's safety and effectiveness or whether it is innovative. Substantial equivalence, in the case of a new device with technologic changes, means that the new device is as safe and effective as its predicate.
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• F inding 4-8 There is no consistent approach for how the FDA de termines the need for clinical data, the type of such data, and the manner in which such data, if available, are integrated into the decision-making process. • F inding 4-9 Because of administrative constraints that make it bur densome for both manufacturers and the FDA, the de novo submis sion process has not met its potential as an alternative regulatory pathway for moderate risk but novel medical devices.
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510(k) "substantial equivalence" decision making process.
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2009c. Medical devices: FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process (GAO-09-190)
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