Medical Devices and the Public's Health The FDA 510(k) Clearance Process at 35 Years (2011) / Chapter Skim
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1 Introduction
1 Introduction
Pages 15-28
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, regulates medical devices and radiation-emitting products.1 The 510(k) clearance process, also called premarket notification, has become a major component of the medical-device regulatory framework2 in the United States.
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clearance process, its conclusions on whether the process is protecting patients optimally and promoting innovation, and its recommendations. This chapter provides a brief overview of medical devices and of the challenges associated with regulating them.
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The FDA seeks to protect and promote the public's health by ensuring that safe and effective medical devices continue to be made available to consumers in a timely manner without unreasonable cost to industry. Payers and consumers expect that the regulatory process will provide reasonable assurance that marketed medical devices are safe and effective.
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." It should be noted, therefore, that premarket clinical trials actually measure efficacy, whereas data derived from postmarketing surveillance (for example, in registries) measure effectiveness.
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Topics covered during the June workshop included the legislative history of the 510(k) clearance process and its current structure, the structure of the medical-device industry and how it is affected by regulation, the regulation of medical devices globally,
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Other means of information-gathering included extensive searches of the medical, scientific, and legal literature, review of information on innovation, review of FDA dockets related to the CDRH internal review of the 510(k) clearance process, and review of CDRH's Preliminary Internal Evaluations, Volumes 1 and 2 and other government reports, such as reports from the Government Accountability Office (GAO, 2009a, 2009b, 2009c, 2009d)
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It started by defining two goals of medical-device regulation: to provide reasonable assurance that marketed devices, throughout their life cycles, are safe and effective according to current standards for the clinical indication at the time of use and to facilitate innovation by allowing prompt access of devices to the market. The committee next developed a list of six attributes, which are presented in Box 1-1.
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And it sought input from stakeholders, such as medical-industry and patient representatives, through requests for public comments and several public meetings. CDRH's report offered seven major preliminary findings and recommendations were included in CDRH's report in three categories: a rational, well-defined, and consistently interpreted review standard; well-informed decision-making; and continuous quality assurance.
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After releasing its preliminary internal evaluations, CDRH published a notice in the Federal Register to request public comments on them. In January 2011, CDRH announced that it was moving forward with several of its recommendations (FDA, 2011)
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24 MEDICAL DEVICES AND THE PUBLIC'S HEALTH BOX 1-2 CDRH's Preliminary Finding and Recommendations from Its Review of the 510(k) Clearance Process A Rational, Well‑Defined, and Consistently Interpreted Review Standard Finding 1: There is insufficient clarity with respect to pivotal terms in the definition of "substantial equivalence." Recommendation 1: CDRH should clarify the meaning of "sub stantial equivalence" through guidance and training for reviewers, managers, and industry.
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Because of time constraints, the committee was unable to study fully the seven recommendations that CDRH referred to the committee. The committee did,
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2010b. CDRH preliminary internal evaluations -- Volume II: Task force on the utiliza tion of science in regulatory decision making: preliminary report and recommendations.
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clearance process: Balancing patient safety and innovation. Washington, DC: The National Acad emies Press.
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