the nature and extent of harm that is associated with products cleared or approved by the FDA and therefore indirectly reflecting on the quality of the FDA review processes. In contrast, if safety surveillance is weak and of limited scope, that injuries are not identified can yield little confidence in the review process—absence of evidence of harm is not evidence of the absence of harm. Therefore, this appendix will review the history of adverse-event monitoring of medical devices.

Consideration of the 510(k) clearance process largely involves Class II devices. Since 1997, most Class I devices have been exempted from 510(k) review. Most Class III devices are subject to FDA review through the premarket approval (PMA) process, not the 510(k) pathway, although 25 types of Class III devices are still eligible to enter the market by the 510(k) clearance process. As recommended in Chapter 7, the committee urges the FDA to cease reliance on the 510(k) process for Class III devices as soon as possible. Once that step is completed, the 510(k) process will apply only to Class II devices—although a few are exempt from 510(k) requirements—and some Class I devices.

In considering the gatekeeping function related to the introduction of new medical products to the market, the Federal Food, Drug, and Cosmetic Act (FFDCA) has adopted a variety of approaches: no government preclearance review whatsoever, a limited preclearance review, or extensive government review. For most drug products, Congress chose detailed review and affirmative approval by the FDA before commercialization, which has led to long and expensive processes of drug development. For medical devices, however, Congress has adopted all three approaches: exemption from any premarket review by the FDA before marketing of a product; limited premarket review through a notification of intent to market, commonly called the 510(k) submission; and thorough review and affirmative approval before launching of a product (through the PMA).

After entering the market, products continue to be subject to a variety of legal requirements and prohibitions, which are enforced primarily by the FDA. Congress has given the FDA diverse powers in a patchwork fashion, usually in response to demonstrated or alleged deficiencies in current systems.3 In medical-device terminology, the requirements are called general and special controls and apply to devices according to the degree of potential


3The laws governing medical devices have evolved separately from those applicable to drugs even though many of the authorities appropriate for one system might seem equally appropriate for the other. The nonparallel development reflects the fact that Congress often approached new issues that emerged in one field of medical products without considering whether the issues might also exist in the other. Thus, for example, with respect to medical devices Congress has given the FDA authority to order the recall of products that violate the law, to require notification of voluntary product removals, and to impose civil money penalties for violations. The FDA has none of those authorities over drugs to the same degree. Conversely, the agency has much more extensive authority over labeling, advertising, and marketing of prescription

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