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.
Official resources
MDR Submission Methods
Manufacturers must submit MDRs electronically via FDA's eMDR system or MedWatch online portal. Paper submissions are no longer accepted except in cases of technical inability. All submissions must include the device identification, description of the event, patient outcome, and corrective actions taken or planned.