this chapter will begin with the FDA’s “general controls”—the regulatory system applicable to devices once they enter the marketplace. Once the “postmarket” system is understood, the supplemental controls provided by premarket review can be better appreciated.

In its “Preliminary Report and Recommendations,” the FDA Center for Devices and Radiological Health (CDRH) 510(k) Working Group states (FDA, 2010a) that

the aim of the 510(k) program is two-fold: (1) to assure, through a quality review process, that marketed devices, subject to general and applicable special controls, provide a reasonable assurance of safety and effectiveness; and (2) to foster innovation. Robust premarket review is an essential component of CDRH’s medical device oversight. CDRH’s postmarket tools, while valuable, have important limitations and are not sufficient to serve as a substitute for high-quality premarket review [emphasis added].

This chapter explores those potential or perceived limitations and the procedures by which the controls are imposed and enforced.

Controls Affecting Marketed Devices

The statute establishes a combination of prohibitions and mandates with which a device and its manufacturer must comply. Some of the mandates are imposed on specific devices by order of the FDA at its discretion; others are adopted through regulations issued by notice-and-comment rule-making. This discussion covers only the legal authority of the FDA, not how that authority may have been used through individual enforcement actions or the exercise of discretion not to act.

Many of the controls apply to all devices, regardless of risk presented or classification; others apply to a subset of devices based on risk but not classification; and a few apply only to devices classified in Class II or Class III. Compliance with the controls is monitored and enforced by the FDA through its own resources and with the assistance of the US Department of Justice (DOJ) and federal courts.

The following text will review prohibitions and mandates related to all devices, prohibitions and mandates related to higher-risk devices, FDA monitoring systems, FDA enforcement powers, and procedural requirements that may affect the FDA’s ability to use the powers granted by law.

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