adults or directing that pediatric questions be examined in studies following the approval of a device.

This chapter provides a descriptive foundation for the later discussion of the adequacy of FDA’s program of postmarket surveillance to protect children. The chapter begins with a brief overview of organizational responsibilities for medical device regulation. It then reviews the premarket regulatory responsibilities of FDA as context for the following description of the agency’s responsibilities for postmarket surveillance of medical devices.2 The last section describes some agency programs and activities, for example, inspections of manufacturers that cover both premarket and postmarket arenas.


Within the Food and Drug Administration, primary responsibility for regulating medical devices (and radiation-emitting electronic products) resides with the Center for Devices and Radiological Health (CDRH). The Center for Biologics Evaluation and Research (CBER) is responsible for regulating medical devices related to blood and cellular products (e.g., kits to test blood for HIV). For combination products that involve a drug and a device or a biological product and a device, the primary regulatory responsibility is assigned to CDRH if the main mode of action of the product is not biological or chemical and does not depend on being metabolized.

Within CDR, the Office of Device Evaluation is responsible for the clearance or approval of medical devices that require premarket review. (The Office of In Vitro Diagnostic Device Evaluation and Safety handles reagents and in vitro diagnostic products.) Another unit, the Office of Science and Engineering Laboratories, contributes to the development of standards and methods for product assessments, performs laboratory evaluations and analyses, and conducts research and testing relevant to medical devices or radiation-emitting electronic products. This unit provides technical support for the development of the device-specific guidance documents as discussed later in this chapter. Although other offices have roles related to postmarket surveillance, the key unit is the Office of Surveillance and Biometrics (OSB). It has three divisions, the Division of Biostatistics, the Division of Postmarket Surveillance, and the Division of Surveillance Systems.

Within OSB, the Division of Postmarket Surveillance oversees the adverse event reporting program, which includes the analysis and investiga-


As noted in Chapter 1, in referring to premarket and postmarket rather than premarketing and postmarketing activities, this report follows the legislative language that provided for this study and the usual (but not invariable) practice of FDA in describing activities that occur prior to or following the entry of a medical product into the market.

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