device is that for electrode lead wires and patient cables (FDA, 1997a). Rather than promulgating mandatory performance standards, FDA has focused on cooperation with other countries and private groups to develop national and international voluntary, consensus standards (Phillips and Less, 1999; see also Merrill, 1994).
Based on provisions of the Safe Medical Devices Act of 1990 (P.L. 101–629), FDA has developed special control guidance documents for several kinds of Class II devices. For example, when it created a separate device category for apnea monitors (to distinguish these devices from the generic category of breathing frequency monitors), FDA presented minimum performance, testing, and labeling recommendations (FDA, 2002m). Other special control guidance documents have been issued in conjunction with the reclassification of a device from Class III to Class II, as was recently done for arrhythmia detector and alarm devices (FDA, 2003h).
Another type of special control, Postmarket Surveillance (as narrowly defined in section 522 of the Federal Food, Drug, and Cosmetic Act) may be ordered by FDA for certain Class II or Class III devices. These orders, which can include the collection of clinical data, are discussed further below and in Chapters 5 and 6. In a 1998 document discussing the elimination of statutory requirements for Section 522 Postmarket Surveillance for certain devices, FDA stated that it “will consider the potential to collect postmarket surveillance data to allow more rapid progress [of a device] to market” (FDA, 1998g, p. 1).
In addition, as a condition of approval for a device that requires premarket approval, manufacturers are to provide FDA with an annual report that describes any changes made to the device during the reporting period. The report must also include a bibliography and summary of published and unpublished reports (that were not part of the PMA application) of clinical or laboratory studies involving the device or similar devices (21 CFR 814.84(b)(2)). (These requirements do not apply to devices cleared under 510(k) provisions.) In certain cases, FDA may request copies of the reports. The summary does not in itself amount to an assessment of the information reported.
In this report, postmarket surveillance for medical devices refers primarily to activities that may be required or promoted by FDA or voluntarily undertaken by manufacturers or others to learn more about the safety and effectiveness of marketed medical devices and to respond to safety concerns. Some surveillance activities such as adverse event reporting cover all classes of medical devices whereas others, notably required postmarket surveillance studies, are restricted to a small subset of devices.