21 CFR Part 803 — Medical Device Reporting
21 CFR Part 803 is the Medical Device Reporting (MDR) regulation. It requires manufacturers, importers, and device user facilities to report to FDA when a device may have caused or contributed to a death, serious injury, or malfunction.
Structure of Part 803
| Subpart | Applies to | Content |
|---|---|---|
| Subpart A (§§ 803.1–803.3) | All | General provisions, definitions |
| Subpart B (§§ 803.10–803.22) | All | General requirements, written procedures, exemptions |
| Subpart C (§§ 803.30–803.33) | User facilities | Reporting requirements for hospitals, nursing homes, etc. |
| Subpart D (§§ 803.40–803.47) | Importers | Reporting requirements for initial importers |
| Subpart E (§§ 803.50–803.58) | Manufacturers | Reporting requirements for device manufacturers |
Key definitions (§ 803.3)
- Malfunction — the failure of a device to meet its performance specifications or otherwise perform as intended; reportable if recurrence would likely cause/contribute to a death or serious injury
- Serious injury — injury that is life-threatening, results in permanent impairment of a body function or permanent damage to body structure, or necessitates medical/surgical intervention to preclude such impairment or damage
- Become aware — the point at which the manufacturer has received or otherwise obtained information suggesting an MDR-reportable event
Manufacturer reporting requirements (Subpart E)
| Event | Timeframe | Form |
|---|---|---|
| Death or serious injury | 30 calendar days | eMDR (MedWatch 3500A) |
| Malfunction likely to cause death/serious injury if recurred | 30 calendar days | eMDR |
| Urgent remedial action required OR FDA requests 5-day reporting | 5 work days | eMDR |
Written MDR procedures (§ 803.17)
Manufacturers must have written MDR procedures that address:
- Internal systems for timely and effective identification, communication, and evaluation of events
- The process for submitting MDRs
- Documentation and record-keeping
- Employee training
MDR event files (§ 803.18)
Manufacturers must maintain MDR event files for all events that were evaluated for MDR reportability — including events that were ultimately determined to be non-reportable. Files must be retained for 2 years from the date of the event or the date it was known to the manufacturer.