Compliance
21 CFR 803
Medical Device Reporting
TL;DR
FDA's regulation for mandatory adverse-event reporting by device manufacturers, importers and user facilities — the MDR rule.
21 CFR Part 803 (the Medical Device Reporting rule) requires manufacturers to report to FDA within 30 calendar days (5 days for events requiring remedial action to prevent unreasonable risk of substantial harm) whenever they become aware that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause death or serious injury if it recurred.
Reports are filed via the eMDR system (eSubmitter / HL7 ICSR). Importers and device user facilities have parallel obligations.
Regulatory anchors
- 21 CFR Part 803
- FDA eMDR Guidance
Related terms
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