The objective of adverse event reporting is to gain information about a medical device that assists FDA in protecting the public’s health by helping “to assure that such device is not adulterated or misbranded and to otherwise assure its safety and effectiveness” (21 USC 360i(a)). Although the statute uses the words “safety and effectiveness,” the specific reporting requirements focus on safety.

Mandatory Medical Device Reporting Program

In response to the Medical Device Amendments of 1976, FDA created the Mandatory Medical Device Reporting (MDR) program (21 CFR 803) for device manufacturers and importers.10 The implementing regulations became effective in 1984.11 The Safe Medical Devices Act of 1990 expanded reporting obligations to cover hospitals and other “user facilities” and device distributors. The Medical Device Amendments of 1992 (P.L. 102–300) added definitions of certain terms and established a single reporting standard for device manufacturers, distributors, and user facilities. Subsequently, the FDA Modernization Act of 1997 eliminated most reporting requirements for distributors, although they are required to maintain complaint files that include reports of adverse events (FDA, 2001i; 21 CFR 803.18(d)). The 1997 amendments also provided for a new surveillance system for user facilities as described later in this chapter.12

10  

In 1973, FDA created a limited, voluntary adverse event reporting program, the Medical Device Laboratory Product Problem Reporting Program (PRP). The program was replaced by the mandatory program in 1984 (Gardner and Flack, 1999).

11  

In addition to these requirements, FDA also requires reporting of adverse device reaction and device defect reports under regulations specifying post-approval requirements for manufacturers that are intended “to provide reasonable assurance, or continued reasonable assurance, of the safety and effectiveness” of an approved device (21 CFR 814.82(a)(9)). Reporting is required when the manufacturer learns of (1) a “mix-up” of the device or its labeling with another product; (2) an “adverse reaction, side effect, injury, toxicity, or sensitivity reaction that is attributable to the device” and that either is not covered by the device’s labeling or is covered by labeling but is unexpectedly more severe or frequent; or (3) “any significant chemical, physical or other change or deterioration in the device, or any failure of the device to meet the specifications established in the approved PMA that could not cause or contribute to death or serious injury but are not correctable by adjustments or other maintenance procedures described in the approved labeling” (FDA, 2002e, unpaged). If the deterioration or other change can be corrected by procedures described in the device’s labeling, then the manufacturer can report the event in its annual report. If reporting is required under these provisions and the MDR provisions, FDA specifies that the MDR provisions shall apply so that duplicate reports are not submitted.

12  

As of July 13, 2005, a “plain language” statement of the reporting rules was in effect, which might change some citations of regulations in this chapter (Federal Register, June 15, 2005, p. 34652).



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement