BOX 3.2
Medical Device Reporting Requirements for Device Manufacturers

  1. Report individual adverse events to FDA within 30 calendar days after learning of a reportable death, serious injury, or device malfunction;

  2. Report individual adverse events within 5 working days after learning of (a) an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or (b) an event for which FDA has made a written request for reports;

  3. Submit supplemental reports within 1 month after obtaining additional information that was not provided in an initial event report;

  4. Submit baseline reports that provide basic information (e.g., brand name, model number) about a device after the first reportable event involving that device;

  5. Provide annual updates of changes in baseline information;

  6. Maintain complete medical device reporting files that include, among other items, information about deliberations and processes used to determine whether an event was reportable; and

  7. Develop and follow written procedures for reporting adverse events.

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.

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