tive devices available to patients nor fostering innovation in the medical-device industry.5 In the past several years, that issue has received attention in the press because of recognized or potential problems with several devices that had been cleared through the 510(k) process, including an artificial hip (Meier, 2010), a patch for injured knees (Harris, 2010a; Mundy and Favole, 2009; Stein, 2010), surgical mesh (Bloomberg News, 2008), and medical-tubing connectors (Harris, 2010b; Shuren, 2010).

In September 2009, the FDA asked the Institute of Medicine (IOM) to review the 510(k) clearance process for medical devices and to answer two questions:

•    Does the current 510(k) clearance process protect patients optimally and promote innovation in support of public health?

•    If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) clearance process optimally?

In response to the FDA’s request, IOM appointed the Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. This report summarizes the committee’s review of the 510(k) 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. It describes the general approach used by the committee to complete its challenging task and includes a discussion of changes that CDRH is making in the 510(k) program. The chapter ends with a roadmap for the rest of the report.


The Federal Food, Drug, and Cosmetic Act (FFDCA)6 defines a device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is

•    Recognized in the official National Formulary, or the US Pharmacopeia, or any supplement to them,


5For example, letter from Representatives Henry A. Waxman, Bart Stupak, and Frank Pallone, Jr., Committee on Energy and Commerce, US House of Representatives, to Joshua M. Sharfstein, Principal Deputy Commissioner, US Food and Drug Administration (May 11, 2009); letter from Carmella Bocchino, America’s Health Insurance Plans, to FDA, Docket FDA-2010-N-0054, Document FDA-2010-N-0054-0047 (March 19, 2010).

6Federal Food, Drug, and Cosmetic Act §201(h), 21 USC § 321(h) (2006).

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