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6 External Factors That Affect the Medical-Device Regulatory System
Pages 149-188

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From page 149...
... However, that regulatory process does not exist in isolation. It is a part of a broad landscape consisting of such additional factors as the increasing complexity of medical devices, the process of innovation, the business environment in which medical devices are developed, and the international medical-device regulatory arena.
From page 150...
... .1 This guidance gave manufacturers autonomy in making decisions about devices with changes that were sufficiently minor as to preclude the need for premarket review. Finally, passage of the FDA Modernization Act in 1997 resulted in exemption of most Class I and many Class II devices from premarket review.2 This Act resulted in decreased numbers of low-risk and, in some cases, moderate-risk devices subject to premarket review.
From page 151...
... The technologic complexity of medical devices has increased sub stantially over the past 35 years as well. A 2010 FDA report states that "devices are unique among medical products in that they are defined by innovation, either through incremental evolution or disruptive revolution" 321 CFR §§ 862–892.
From page 152...
... clearance process as the basis for demonstrating substantial equivalence. The increasing complexity of medical devices is reflected in how predicates 4FDA Docket Number FDA–2010–N–0054.
From page 153...
... Combined uses of medical products present complex regulatory issues because the resulting treatment or diagnostic test 5In 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)
From page 154...
... in the Medical Device User Fee and Modernization Act of 2002. Combination product is a term of art that has a specific meaning.6 To qualify as a combination product, the two (or more)
From page 155...
... -cleared device. OCP also has a role in situations in which such products as medical devices and drugs are used in concert but not as true combination products.
From page 156...
... software is incorporated directly into medical devices. The FDA's software validation guidance addresses that situation, noting that "the use of off-the-shelf software in automated medical devices and in automated manufacturing and quality system operations is increasing" (FDA, 2002)
From page 157...
... © 2008 IEEE. bitmap way to know the number of devices on the market or how many of them use software, it is not possible to know whether the change is related to the increasing proportion of software in medical devices or whether it is a signal of new or different types of problems and vulnerabilities in medicaldevice software.
From page 158...
... . The Guidance for Premarket Submissions for Software Contained in Medical Devices for industry and FDA staff issued on May 11, 2005, poses questions about problems with OTS medical-device software (FDA, 2005a)
From page 159...
... Such optimism is shared by hardware testers but seems to be extreme in software testers. Indeed, Beck (2004)
From page 160...
... Software Validation Requires Interpretation Within the System Context The FDA provides guidance on how software can be validated to ensure that it is performing its functions correctly (FDA, 2002) : Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.10 Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer's quality system.
From page 161...
... 5 bitmaps plus vector elements In other words, the FDA requires objective evidence that demonstrates predictability and consistency of function. To provide that evidence, a medical device must be viewed as part of a larger system in which it functions.
From page 162...
... As a consequence, ensuring the safety of software in a medical device requires presenting a convincing argument that the actions taken, when viewed collectively, support the claim that the device is likely to be safe. Similar arguments are made in other disciplines, such as nuclear power–plant safety, in which a "safety
From page 163...
... A • set of arguments that link the claims to the evidence. A However, software developers and device manufacturers often focus too much on producing evidence and too little on building the associated arguments, analyzing their soundness, and accounting for uncertainty (Pfleeger, 2005)
From page 164...
... . Susan Bartlett Foote in her book Managing the Medical Arms Race: Public Policy and Medical Device Innovation cites several variations, including "certain technical knowledge about how to do things better than the existing state of the art" (Teece, 1986)
From page 165...
... In the context of devices, a whitepaper from CDRH in February 2011 titled CDRH Innovation Initiative states that "new scientific discoveries or novel ideas are often at the root of innovative medical device development -- whether the product is a transformative technology, a modified version of an already marketed model, or a novel application of existing tools or scientific approaches" (FDA, 2011b)
From page 166...
... similarly concluded that "clinical needs provide opportunities for medical device innovation" through identifying an unmet or undermet clinical need, harnessing new insight into the physiology of a disease or a new diagnostic approach, new developments in technology, or some combination of such factors. In its 2004 report, updated in 2010, Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, the FDA outlined a critical path for medical-product development from basic research to FDA approval (FDA, 2010c)
From page 167...
... clearance process optimally protects patients and promotes innovation in support of public health. The committee believes that given the broad interpretation of the term it should define innovation not simply as a change but as a favorable change in the context of public health.
From page 168...
... Congress showed some concern during a House Subcommittee on Health hearing in 1987 that equivalence would freeze the world as it was, indicating that technologic improvements had continued to occur in the 10 years since the initial legislation but that under the concept of substantial equivalence "new devices need not incorporate these improvements: they need only be as safe and effective as similar devices on the market before 1976."11 In the late 1980s, the FDA redefined the term substantially equivalent and Congress endorsed this interpretation with the Safe Medical Devices 11Memorandum 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
From page 169...
... Medical devices are developed by commercial interests that range from small startup companies to established conglomerates. Publicly traded US medical-device companies generated revenues of $188.8 billion in 2008
From page 170...
... The vast majority of medical devices subject to FDA premarket review -- more than 90% -- are brought to market via the 510(k) clearance process.
From page 171...
... clearance of products, which has created an unfavorable environment for development of medical devices. Additional time to 510(k)
From page 172...
... Finding 6-5 Industry-funded assessments of the effects of the 510(k) clearance process report that implementation of the process leads to a lack of predictability and transparency, which in turn has an adverse effect on venture-capital investment.
From page 173...
... Lowrisk imported devices do not require premarket review, only registration and listing and, as appropriate, conformity with other regulations, such as quality-system regulations and labeling requirements. Medical-device regulations in the United States were developed largely at a time when the medical-device industry was primarily domestic, but now medical devices are global products in a global market.
From page 174...
... Beginning with a clean slate, however, gave the EU the opportunity to put into place a logic model that used the latest thinking in risk analysis. In the United States, the standard for clearance is substantial equivalence to a previously cleared device; but the EU and other countries that tightly regulate medical devices do not rely on this standard.
From page 175...
... Among its objectives were that "active implantable medical devices must give patients, users and other persons a high level of protection and achieve the intended level of performance when implanted in human beings" and that "national provisions ensuring that safety level should be harmonized in order to guarantee the free movement of active implantable medical devices without lowering existing and justified levels of safety in the Member States" (European Commission, 2001)
From page 176...
... In 2007, Directive 2007/47/EC made extensive amendments to the MDD, including the addition of software to the definition of a medical device and making software validation part of the essential requirements that had to be met to establish conformity with safety standards. A device must perform its "intended purpose" according to its labeling.
From page 177...
... . If the manufacturer chooses to comply with a standard that is recognized by the European Commission as offering "presumption of conformity" with one or more essential requirements (known as harmonized standards)
From page 178...
... . Manufacturers can also turn to guidance 14The essential requirements, classification rules, and conformity-assessment procedures are substantially different for in vitro diagnostic medical devices, which are regulated under their own directive.
From page 179...
... . Notified Bodies The directives contain provisions for the establishment of NBs, the backbone of the European regulatory structure for medical devices.
From page 180...
... The CA then notifies the European Commission and the other member states as to which private organizations have been judged to be competent according to the standards laid out in the directives and for which tasks. The commission maintains an updated list of the NBs and makes this information available to the public through the New Approach Notified and Designated Organisations Web site (NANDO, 2011)
From page 181...
... . The committee is not aware of any comprehensive evaluations of the European system based on postmarketing surveillance or adverse-event reports.
From page 182...
... A collaborative body whose purpose is to improve public health and safety, promote international trade, and provide guidance to countries with developing medicaldevice regulatory systems, the GHTF works to form consensus among the partners on regulatory and technical standards and postmarketing surveillance efforts. Many international agreements are in place regarding medical devices and their regulatory requirements for importation.
From page 183...
... Given the lack of data needed to evaluate the program and the small number of devices eligible, it is not possible to determine what factors contribute to the lack of industry participation in the program. Finding 6-8 Other countries that tightly regulate medical devices do not rely solely on substantial equivalence to a predicate for premar 16A list of eligible devices and information on the alternative format (developed by the Global Harmonization Task Force)
From page 184...
... The Global Harmonization Task Force also does not offer as part of its guidance a predicate-based system for premarket review of medical devices.
From page 185...
... 2001. Interface with other directives: Guidelines relating to the application of: The council directive 90/385/EEC on active implantable medical devices the council directive 93/42/EEC on medical devices.
From page 186...
... 2008. Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices (STED)
From page 187...
... 2008. Security and privacy for implantable medical devices.
From page 188...
... 2011. On the impact of medical device regulation on jobs and patients.


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