2

Key Medical-Device Legislative and Regulatory Actions

Regulation of medical devices began in 1938 and reflected the technologically relatively simple devices then on the market. By the 1970s, the framework was no longer adequate or flexible enough to deal with the wide array of device types, the increasing sophistication of many technologies, and the occasional public-health disasters associated with a few devices. In 1976, Congress replaced the 1938 structure with a comprehensive system. As with most major new laws, refinements were needed, and in 1990 and 1997, Congress passed sets of substantial changes in the 1976 statute. Those three enactments make up the present framework.

The ability of the Food and Drug Administration (FDA) to carry out the directives of Congress has been constrained by chronically inadequate appropriations to the agency (FDA Science Board, 2007; GAO, 1983, 1989, 1992, 1995, 1996, 1997, 2009a; OTA, 1984).1 In 2002 and 2007, Congress passed legislation that authorized the agency to charge the device industry user fees to expand premarket-review capacity. The user-fee legislation did not change the statutory structure, but it did require that the FDA meet performance goals.

This chapter will briefly review that history. Appendix A contains an extensive chronologic inventory of legislative enactments and Congressional examination of the implementation of the device laws.

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1H.R. REP. No. 101-808, at 13 (1990); see also S. REP. No. 101-513, at 14-15 (1990).



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2 Key Medical-Device Legislative and Regulatory Actions R egulation of medical devices began in 1938 and reflected the techno- logically relatively simple devices then on the market. By the 1970s, the framework was no longer adequate or flexible enough to deal with the wide array of device types, the increasing sophistication of many technologies, and the occasional public-health disasters associated with a few devices. In 1976, Congress replaced the 1938 structure with a compre- hensive system. As with most major new laws, refinements were needed, and in 1990 and 1997, Congress passed sets of substantial changes in the 1976 statute. Those three enactments make up the present framework. The ability of the Food and Drug Administration (FDA) to carry out the directives of Congress has been constrained by chronically inadequate appropriations to the agency (FDA Science Board, 2007; GAO, 1983, 1989, 1992, 1995, 1996, 1997, 2009a; OTA, 1984).1 In 2002 and 2007, Congress passed legislation that authorized the agency to charge the device industry user fees to expand premarket-review capacity. The user-fee legislation did not change the statutory structure, but it did require that the FDA meet performance goals. This chapter will briefly review that history. Appendix A contains an extensive chronologic inventory of legislative enactments and Congressional examination of the implementation of the device laws. 1H.R. Rep. No. 101-808, at 13 (1990); see also S. Rep. No. 101-513, at 14-15 (1990). 29

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30 MEDICAL DEVICES AND THE PUBLIC’S HEALTH THE 1938 ACT The original FDA statute, the Pure Food and Drug Act of 1906, did not cover medical devices. When Congress replaced it with the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA), it extended the law to medical devices, but for all intents and purposes devices were treated as drugs, and the definitions of the two categories overlapped. The overlap enabled the FDA, after a change in the drug law in 1962, to impose rigorous premarket approval of some products that today would be deemed devices. In the 1960s, Presidents Kennedy, Johnson, and Nixon all called for new regulatory legislation specific to medical devices. By the early 1970s, several high-profile public-health problems with medical devices had led to political momentum for a device statute.2 THE 1976 ACT The Medical Device Amendments of 1976 established an elaborate and detailed scheme, more than doubling the length of the FFDCA.3 After differentiating drugs from devices, the law created a broad array of authori- ties for the FDA to regulate devices after they had entered the marketplace. Moreover, in contrast with the US drug laws of the time, Congress limited premarket approval to only a small universe of devices. Where the drug law generally treated all drugs alike, the new device amendments created three categories of devices that were based on the risks presented and the ability of postmarketing controls to manage them. Only the highest-risk category would require agency review and approval as a precondition for commercial sale and routine medical use. The other two categories would be subject not to a rigorous review but merely to a requirement that the manufacturer of a device in one of the categories notify the FDA, at least 90 days before commencing marketing, of its intent to distribute the product commercially. That requirement was set forth in Section 510(k) of the FFDCA and thus is called a 510(k) notification. The new law directed the FDA to categorize the device types in the universe of devices on the market when the 1976 law was enacted (so-called preamendment devices) into three categories—called Class I, Class II, and Class III—on the basis of the definitions that Congress adopted. Thereafter, under the statute, a device type could be transferred from one class to an- other on the basis of new information showing that it would now be more appropriately assigned to a different class. The criteria for the three classes were stated in the 1976 law as follows: 2H.R.Rep. No. 94-853, at 8 (1976). 3Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) (hereinafter MDA).

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31 LEGISLATIVE AND REGULATORY ACTIONS • Class I device is one of which the general postmarketing controls A would be sufficient to provide reasonable assurance of safety and effectiveness. Class I can also include any device on which there is insufficient information to judge the adequacy of the controls but that is not represented as being for use in supporting or sustaining human life (or in preventing impairment of health) and does not present an unreasonable risk of illness or injury.4 • Class II device is one that cannot be placed into Class I, because A the general controls are not sufficient by themselves to provide rea- sonable assurance of safety and effectiveness but on which there is sufficient information to establish a performance standard to pro- vide reasonable assurance. A performance standard might include provisions regarding the construction, components, ingredients, and properties of the device and its compatibility with power systems; provisions for the testing of the device to ensure conformity with 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.5 • Class III device is one that is represented as being for use in sup- A porting or sustaining life (or in preventing impairment of health) or that creates a potential unreasonable risk of illness or injury and that cannot be placed into Class I or Class II, because the general controls are inadequate to give reasonable assurance of safety and effective- ness and because there is not sufficient information to establish a performance standard to provide the requisite assurance.6 Congress directed that the safety and effectiveness of a device were to 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.”7 The classification of preamendment devices did not include any evalua- tion 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, includ- ing 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 4FFDCA § 513(a)(1)(A), 90 Stat. 540 (1976) (subsequently amended). 5FFDCA § 513(a)(1)(B), 90 Stat. 541 (1976) (subsequently amended). 6FFDCA § 513(a)(1)(C), 90 Stat. 541 (1976) (subsequently amended). 7FFDCA § 513(a)(2), 21 USC § 360c(a)(2) (2006).

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32 MEDICAL DEVICES AND THE PUBLIC’S HEALTH panels nor the FDA itself undertook an assessment of the clinical safety or effectiveness of individual devices during the 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 premarket approval (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. Thus, preamendment devices in Class I and II were never subjected to a comprehensive FDA evaluation for safety or effectiveness. The classification process was not completed until 1988. Finding 2-1 The safety and effectiveness of individual preamend- ment Class II medical devices has not been systematically reviewed. Continued use in clinical practice, however, provides at least a level of confidence in the safety and effectiveness of preamendment Class II medical devices still on the market. In creating the new system, Congress also had to address how devices that were not on the market when the law was passed (so-called postamend- ment devices) could get onto the market. First, it concluded that if a new device were “substantially equivalent” to a preamendment device, it could enter the market on the same terms and conditions as the preamendment device. In other words, if the preamendment device had been placed into Class III, the substantially equivalent postamendment device would be in Class III and subject to PMA review when the FDA called for the PMA ap- plication for the preamendment device. If the preamendment device were placed into Class I or Class II, the substantially equivalent postamendment device would be permitted into the market subject to whatever controls or performance standards were applicable to the preamendment device. If the preamendment device had not yet been classified, the substantially equiva- lent postamendment device could come onto the market and be placed into the same class as the preamendment device when it was classified. When a manufacturer proposed to introduce a new (postamendment) device, includ- ing a modification of a preamendment device, it submitted a 510(k) notice identifying the preamendment device to which substantial equivalence was claimed and the supporting evidence, if needed or requested by FDA. Second, Congress said that if the postamendment device were not “sub- stantially equivalent” to any preamendment device, it would be automati- cally placed into Class III. To enter the market, the manufacturer would have

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33 LEGISLATIVE AND REGULATORY ACTIONS to obtain approval of a PMA application or successfully get the agency to reclassify the device into Class I or Class II. Finding 2-2 The 510(k) clearance process was not designed in 1976 to evaluate the safety and effectiveness of new medical devices but only to assess their similarity to preamendment devices. Congress did not define substantial equivalence in the 1976 amend- ments, and the legislative history contains a one-paragraph discussion that is, at best, ambiguous (FDA, 2010). Because of resource limitations, the FDA tended to find that postamendment devices were substantially equiva- lent to preamendment devices. To rule otherwise would increase the need for personnel to review PMA applications or to reclassify postamendment devices down from Class III, and both would have been labor-intensive activities. Furthermore, as time passed after 1976, the FDA adopted a practice of permitting a chain of devices to link a new postamendment de- vice to earlier postamendment devices that ultimately could be traced back to a preamendment device; that is, Device A might be found substantially equivalent to Device B, which had been found equivalent to Device C, which had been found equivalent to Device D, and so on back to a preamend- ment device (FDA, 2010). The effect of those actions was that the 510(k) process evolved into a system that tended to find substantial equivalence far more often than nonequivalence.8 Between fiscal years 1976 and 2009, only 1–4% of 510(k) notifications submitted annually were found by the FDA to be not substantially equivalent (FDA, 2010, p. 39; GAO, 1997, p. 7; OTA, 1984, p. 104). Finally, the resource constraints delayed the promulgation of regulations calling for PMA applications for preamendment Class III devices and estab- lishing performance standards for Class II devices.9 Until those two steps occurred, Class II and Class III devices were subject to the same standard for market entry as Class I devices: demonstration of substantial equivalence to a preamendment device. 8Memorandum 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). 91976 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]); FFDCA § 515(b), 21 USC § 360e(b) (2006).

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34 MEDICAL DEVICES AND THE PUBLIC’S HEALTH THE 1990 ACT After a long series of investigations and hearings by Congress—through its committees, the Government Accountability Office (then called the Gen- eral Accounting Office), and the Office of Technology Assessment—Con- gress passed the Safe Medical Devices Act of 1990. The goal was to address deficiencies that Congress identified in the 1976 law.10 Congress was clearly unhappy with the almost complete lack of prog- ress in bringing all Class III devices into the PMA application system. To reduce that workload, the new law authorized the FDA to reclassify Class III devices that no longer warranted being in this category. For devices that remained in Class III, Congress directed the FDA to set a schedule—no later than December 1996—for promulgating the regulations needed to require submission of PMA applications. No final deadline for completing the pro- cess was set, however. (As of April 2011, it was not finished.) For Class II devices, the new law addressed the FDA’s failure to establish performance standards. Congress broadened the scope of the FDA’s author- ity so that requirements or restrictions (called special controls) in addition to performance standards could be imposed; it made the imposition of special controls discretionary rather than mandatory; and it simplified the process by which performance standards could be established. Congress also added new postmarketing tools to the agency’s portfolio, underscoring the belief that premarket clearance would never be sufficient to protect public health. With respect to the 510(k) process specifically, Congress adopted the more liberal interpretation of substantial equivalence that the FDA had been applying during the previous decade and thereby eliminated a fear that a court might declare that interpretation to violate the 1976 act. The agency, for example, had decided that a rigid reading of equivalence would not permit product improvements in safety and effectiveness; instead, a postamendment device could be determined to be substantially equivalent to another device even though it was claimed to be safer or more effective than the predicate with which it claimed comparability.11 The standard applied was one of “noninferiority”; that is, the new device had to be “as safe and effective” as the reference device and did “not raise different questions of safety and effectiveness” from the reference device. (The FDA added a gloss on the interpretation of the latter criterion, saying that a new device could 10H.R. Rep. No. 101-808, at 13 (1990); see also S. Rep. No. 101-513, at 14-15 (1990). 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. 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).

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35 LEGISLATIVE AND REGULATORY ACTIONS be cleared by the 510(k) process if it did not “raise new types of questions of safety and effectiveness” [IOM, 2010, p. 11].) In addition, the new law permitted the establishment of equivalence to marketed preamendment or postamendment devices, called predicate devices, with the exception of devices approved by PMA. That change eliminated the need ever to construct a chain of 510(k) clearances back to a pre-1976 device. The only products that could not be considered as predicates were ones that had been removed from the market by order of the FDA or a federal court. Finding 2-3 A 510(k) decision made by the FDA creates a precedent that is legally binding on the agency unless it has rescinded the decision or has barred the device covered by that decision from the market through other legal actions. The relationship between the 510(k) process and innovation changed slightly in 1990. The 1976 law, literally read, would preclude a manufac- turer’s use of the 510(k) process for a device that the company claimed would be safer and more effective than the preamendment device; changes that raised any issue of safety or effectiveness were (in theory, at least) to go through the PMA process instead. Moreover, from a narrow legal stand- point, successful compliance with the 510(k) process allowed a manufac- turer only to market the covered device. Unlike laws that create a period in which a company has exclusive rights to sell a product (for example, under a patent or data-exclusivity provision), 510(k) established no special benefit for the first manufacturer to bring a certain device to market. Two companies could submit 510(k)s for competing products, each based on substantial equivalence to the same preamendment device, and each could be cleared without regard to the other. In 1990, in ratifying the FDA interpretation of the substantial- equivalence standard as a noninferiority test and permitting clearance of products that did not raise different safety or effectiveness questions, Con- gress recognized that many innovative developments could be cleared with the 510(k) process and thus avoid the more burdensome PMA system. By eliminating the theoretical requirement of being able to trace a lineage back to a preamendment device, the 1990 law permitted comparisons with newer, more innovative state-of-the-art products. In contrast, the 1990 legislation did not compel any manufacturer to evolve with the state of the art. As long as the submitter could find any lawfully marketed device to which it could successfully claim substantial equivalence, the agency would have to clear the 510(k) notification. More- over, the FDA was not given any mandate to consider whether a proposed device under a 510(k) notification was in fact innovative. A fair reading

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36 MEDICAL DEVICES AND THE PUBLIC’S HEALTH of the statutory scheme is that the FDA was to facilitate the clearance of new products that did not raise novel questions of safety and effectiveness, whether or not the product was an innovation. Presumably, the more ef- ficiently and expeditiously Class I and Class II products were cleared, the more likely it would be that innovative products would reach the market. Finding 2-4 The 510(k) clearance process was not designed to reward, recognize, or encourage innovation. At most, promotion of innovation was a byproduct of a process that, by minimizing unnecessary regulatory burdens, facilitated the entry into the mar- ket of new devices that did not raise novel questions of safety or effectiveness. The definition of “substantial equivalence” used by the FDA in the 1980s and ratified by Congress in 1990 also permitted the FDA to require evidence of safety and effectiveness, including clinical studies, when neces- sary to determine whether a difference in technologic characteristics between the new device and its predicate rendered the new device less safe or effective than the predicate or raised different questions of safety and effectiveness from the predicate. This situation is the only one in which the FDA can con- sider the safety and effectiveness of a device as part of the 510(k) process. If, despite the change in technologic characteristics, the new device was as safe and effective as the predicate, it would be found to be substantially equiva- lent. About 15% of Class II and Class III 510(k) submissions for which the FDA reached a determination of substantial equivalence or nonsubstantial equivalence in FY 2005–2007 had new technologic characteristics (GAO, 2009b). Some 99.5% received a determination of substantially equivalent. Because the assessment of substantial equivalence generally did not re- quire evidence of safety or effectiveness of a device and because a preamend- ment device to which equivalence was established was not itself specifically reviewed for safety or effectiveness, the FDA made clear from the outset that clearance of a 510(k) notification was not a determination that the cleared device was safe or effective. That position was reiterated by the agency nu- merous times (OTA, 1984, p.128).12 The US Supreme Court accepted this interpretation in a 1996 opinion (Medtronic, Inc. v. Lohr, 518 U.S. 470). In that opinion, the Court quoted favorably a critic of the 510(k) process: 12Memorandum 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; Brief 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).

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37 LEGISLATIVE AND REGULATORY ACTIONS 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 latter 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 latter device may also be risky or ineffective.13 Finding 2-5 With limited exceptions, a determination by the FDA that one device is “substantially equivalent” to another device does not reflect an FDA evaluation of the safety or effectiveness of either device. THE 1997 ACT The Food and Drug Administration Modernization Act (FDAMA) was enacted by Congress in 1997. Congress had concluded that the FDA regula- tory 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 promising new devices.”14 In general, FDAMA restricted the agency’s authorities and eased the burdens on manufacturers seeking 510(k) clearance.15 The law specifically instructed the FDA to consider the extent to which postmarketing controls might expedite the preclearance process. Congress eliminated the requirement for 510(k) notifications for most new Class I devices and some Class II devices to permit the FDA to con- centrate its resources on higher-risk devices. The act imposed various con- straints on the scope of review of 510(k) submissions so that the agency in general could no longer consider as grounds for a nonsubstantially equiva- lent determination other potential off-label uses of a proposed device16 or whether a manufacturer was in compliance with regulations pertaining to good manufacturing practices.17 Congress also directed that when a pro- posed new device included a change in technology such that the FDA had to determine whether the device was as safe and effective as its predicate, the FDA was not to request any evidence beyond the “least burdensome” means to demonstrate equivalence.18 Nothing in the legislative history of the 13Lohr, 518 U.S. at 493-94 (citations omitted). 14H.R. Rep. No. 105-307, at 13 (1997). 15Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (1997). 16The FDA may add labeling statements cautioning about specific foreseeable off-label uses. FFDCA § 513(i)(1)(E), 21 USC § 360e(i)(1)(E) (2006). 17The FDA may refuse to clear a 510(k) submission if it finds a substantial likelihood that noncompliance will “potentially present a serious risk to human health.” FFDCA § 513(f)(5), 21 USC § 360c(f)(5) (2006). 18FFDCA § 513(i)(1)(D), 21 USC § 360c(i)(1)(D) (2006).

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38 MEDICAL DEVICES AND THE PUBLIC’S HEALTH 1997 Act suggests that Congress disagreed with the Supreme Court’s 1996 opinion that clearance of a 510(k) notification was not a determination that the cleared device was safe or effective. The legislation also limited the application of some postmarketing tools to Class II and Class III devices and eased reporting requirements for adverse medical events. Finding 2-6 The 510(k) clearance process has evolved from 1976 to the present through administrative and legislative changes, nar- rowing the array of issues that the FDA may consider in a 510(k) review and limiting the type of evidence that the FDA could require. Over 35 years, there has been a high frequency of finding substan- tial equivalence. The PMA application has always been perceived as more onerous to manufacturers. As the 510(k) process was modified to facilitate clearance of new and improved products, the disincentives accompanying the PMA application became more apparent. Finding 2-7 The gap in relative burdens on manufacturers between the 510(k) process and the PMA process created by the 1976 law has been maintained by administrative and legislative changes, which have encouraged preferential use of the 510(k) process. THE 2002 AND 2007 ACTS After years of insufficient resources for the PMA and 510(k) clearance processes (FDA Science Board, 2007; GAO, 1983, 1989, 1992, 1995, 1996, 1997, 2009a; OTA, 1984). Congress enacted a 5-year user-fee program in 2002 and renewed it in 2007. The enactments did not make fundamental changes in the regulatory framework. They did, however, provide supple- mental funding for the FDA to use in reviewing of 510(k) submissions and PMA applications. Every establishment in which a device is manufactured must pay a fee with its required annual registration of names and places of business. Fees also must accompany each 510(k) submission, each original PMA application, each PMA supplement, and some other applications. The fees may be used only to support review activities, not other Center for De- vices and Radiological Health (CDRH) operations, such as postmarketing safety monitoring and enforcement activities. User fees are required only if two basic conditions are met. First, Congress must continue to appropriate a level of funding for CDRH re- view activities. The user fees are intended to augment, not replace, general revenues from taxes. The FDA may not collect user fees if public funding

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39 LEGISLATIVE AND REGULATORY ACTIONS falls below a specified level (calculated with a complex formula). Second, the agency must meet performance standards (such as completing reviews on at least 90% of all 510(k) notifications within 90 days of submission). The standards are established in correspondence between the Department of Health and Human Services and Congress. The FDA is increasingly dependent on user-fee revenues to operate its review programs. To meet the minimum requirements for matching general- revenue funds, the agency has been forced to divert resources from other activities that are not subject to user fees or user-fee goals. To sustain user- fee funding, the agency faces growing pressure to meet the performance targets. A failure to either provide matching resources or meet performance standards could result in a catastrophic disruption of all review activities. The user-fee program has a 5-year term. It will expire in 2012, unless renewed by the current Congress. Finding 2-8 Congressional appropriations for operation of the 510(k) clearance process have been unstable and frequently inad- equate throughout its 35-year life. User fees have increased the level of funding for premarket review activities but not other CDRH op- erations. The 5-year term of the user-fee program and the risk that it might lapse if various conditions are not met do not ensure stability. SUMMARY OF FINDINGS • inding 2-1 The safety and effectiveness of individual preamend- F ment Class II medical devices has not been systematically reviewed. Continued use in clinical practice, however, provides at least a level of confidence in the safety and effectiveness of preamendment Class II medical devices still on the market. • inding 2-2 The 510(k) clearance process was not designed in 1976 F to evaluate the safety and effectiveness of new medical devices but only to assess their similarity to preamendment devices. • inding 2-3 A 510(k) decision made by the FDA creates a precedent F that is legally binding on the agency unless it has rescinded the de- cision or has barred the device covered by that decision from the market through other legal actions. • inding 2-4 The 510(k) clearance process was not designed to re- F ward, recognize, or encourage innovation. At most, promotion of in- novation was a byproduct of a process that, by minimizing unneces- sary regulatory burdens, facilitated the entry into the market of new devices that did not raise novel questions of safety or effectiveness. • inding 2-5 With limited exceptions, a determination by the FDA F that one device is “substantially equivalent” to another device does

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40 MEDICAL DEVICES AND THE PUBLIC’S HEALTH not reflect an FDA evaluation of the safety or effectiveness of either device. • inding 2-6 The 510(k) clearance process has evolved from 1976 F to the present through administrative and legislative changes, nar- rowing the array of issues that the FDA may consider in a 510(k) review and limiting the type of evidence that the FDA could require. Over 35 years, there has been a high frequency of finding substantial equivalence. • inding 2-7 The gap in relative burdens on manufacturers between F the 510(k) process and the PMA process created by the 1976 law has been maintained by administrative and legislative changes, which have encouraged preferential use of the 510(k) process. • inding 2-8 Congressional appropriations for operation of the 510(k) F clearance process have been unstable and frequently inadequate throughout its 35-year life. User fees have increased the level of fund- ing for premarket review activities but not other CDRH operations. The 5-year term of the user-fee program and the risk that it might lapse if various conditions are not met do not ensure stability. REFERENCES FDA (Food and Drug Administration). 2010. CDRH preliminary internal evaluations—Volume I: 510(k) working group preliminary report and recommendations. Silver Spring, MD: Food and Drug Administration. FDA Science Board. 2007. FDA science and mission at risk: Report of the subcommittee on science and technology. Silver Spring, MD: Food and Drug Administration. GAO (Government Accountability Office). 1983. Federal regulation of medical devices— problems still to be overcome (HRD-83-53). Washington, DC: General Accounting Office. ———. 1989. FDA resources: Comprehensive assessment of staffing, facilities, and equipment needed (HRD-89-142). Washington, DC: General Accounting Office. ———. 1992. FDA regulations: Sustained management attention needed to improve timely issuance (T-HRD-92-19). Washington, DC: General Accounting Office. ———. 1995. Medical devices: FDA review time (PEMD-96-2). Washington, DC: General Accounting Office. ———. 1996. FDA resources (PEMD-96-8R). Washington, DC: General Accounting Office. ———. 1997. Medical devices: FDA review times, 1989 through 1996 (HEHS-97-146R). Washington, DC: General Accounting Office. ———. 2009a. FDA faces challenges meeting its growing medical product responsibilities and should develop complete estimates of its resource needs (GAO-09-581). Washington, DC: Government Accountability Office. ———. 2009b. FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process (GAO-09-190). Washington, DC: Government Accountability Office. IOM (Institute of Medicine). 2010. Public health effectiveness of the FDA 510(k) clearance process: Balancing patient safety and innovation. Washington, DC: The National Acad- emies Press. OTA (Office of Technology Assessment). 1984. Federal policies and the medical devices indus- try. Washington, DC: Congress of the United States, Office of Technology Assessment.