SOURCES: 21 USC 360i; 21 CFR 803.10; FDA, 1997b, 2000f.
caused or played a role in causing, (2) report device-related malfunctions that could cause a death or serious injury, (3) establish and maintain adverse event and complaint files, and (4) submit certain follow-up or summary reports to FDA. In contrast to the provisions for adverse drug event reporting, the reporting requirements for medical devices do not distinguish between expected (e.g., listed in a drug’s labeling) and unexpected adverse events (21 CFR 314.80; FDA, 2001f).
In their reports, manufacturers must include information about whether a device was returned and evaluated, the method and findings of evaluation, and any remedial action such as a recall or labeling change. In addition to requirements for adverse event reporting, separate “quality system” regulations include requirements for timely review and evaluation of complaints and for maintenance of complaint files (21 CFR 820.198).
Manufacturers are not required to report all complaints or information received but rather must evaluate this information to determine whether it involves a reportable event. Companies may receive information or complaints by telephone, fax, mail, or e-mail from consumers, health care workers, health care facilities, vendors, or their own sales or service representatives or other employees. They may also become aware of possible problems through scientific articles, news reports, professional conference presentations, or communications from FDA or other government agencies.