As described in more detail below, FDA’s postmarket surveillance programs include adverse event reporting and analysis, medical device tracking for certain devices, and focused studies of selected products, including epidemiologic and other analyses undertaken or supported by FDA and studies required of manufacturers. When surveillance activities identify an important problem with a device, FDA is also responsible for identifying an appropriate response, for example, a public notice suggesting precautions for physicians or a request that a manufacturer recall a product.

Beyond these kinds of regulatory postmarket programs, many kinds of knowledge-building activities may occur after a device is approved for marketing. Such activities may be undertaken or funded by manufacturers or by other government agencies (e.g., National Institutes of Health [NIH] or Veterans Administration) for primary purposes other than surveillance. Such purposes include expanding the evidence base for clinical decisions, supporting coverage decisions by Medicare or other payers, identifying less costly ways of delivering health care, or extending the indications for use for which a device is explicitly approved. Thus, a manufacturer’s self-initiated postmarket study of a device to support FDA approval of a new use arguably does not meet the definition of surveillance, although such a study might generate information, including adverse event reports, that is also relevant to approved indications. Likewise, the investigation of radiation doses to children from repeated computer-assisted tomography might be undertaken in the first instance to generate knowledge to guide clinical practice, but such knowledge might also prompt adaptations by manufacturers of these devices and safety guidance from FDA (see, e.g., Feigal, 2001b).

In addition to clinical studies, clinicians may present or publish case reports of patients who have had a device-related problem that fits the definition of an adverse event. Although these clinicians may not knowingly be engaged in surveillance, their case reports may prompt attention from FDA or manufacturer surveillance programs. One challenge for FDA and for others interested in early warning of potential safety problems involves how to take better advantage of physician experiences in recognizing such problems without creating unduly burdensome or unproductive procedures or programs. Chapter 4 returns to this issue.

Mandatory and Voluntary Adverse Event Reporting

The Federal Food, Drug, and Cosmetic Act authorizes FDA to establish a system for the reporting of adverse events associated with legally marketed medical devices (21 USC 360i). Current FDA programs, which cover all classes of medical devices, provide for mandatory reporting from manufacturers, importers, and user facilities and voluntary reporting from others, including consumers and health care professionals. (Chapter 4 looks at adverse event reporting in more depth.)



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