In Force Checked October 24, 2026
In force and unchanged by the QMSR. Manufacturers and importers file reports electronically (eMDR).
What It Covers
When device manufacturers, importers and user facilities must tell FDA about deaths, serious injuries and malfunctions, and what they must keep on file.
Who It Applies To
Manufacturers and importers of devices marketed in the US, and device user facilities such as hospitals and nursing homes, each with their own duties.
Key Requirements
- Manufacturers report deaths and serious injuries within 30 calendar days of becoming aware.
- Malfunctions that would be likely to cause or contribute to death or serious injury if they recurred are also reported within 30 days.
- Five-work-day reports where remedial action is needed to prevent an unreasonable risk of substantial harm, or when FDA asks.
- Written MDR procedures (§803.17) and MDR event files (§803.18).
What an Auditor Asks to See
- The MDR procedure and who decides reportability.
- Complaint files showing the date of awareness and the reportability decision with its reasoning.
- Submitted eMDRs and evidence they were on time.
Where Systems Fall Short
- The “became aware” date never recorded, so timeliness cannot be shown.
- Malfunction reportability judged differently from one complaint to the next.
How QES Helps
Complaint and MDR procedures rebuilt so every decision is dated, reasoned, and trended.
Related Standards
Sources. eCFR — 21 CFR Part 803 (opens in a new tab). Status checked October 24, 2026. This page summarizes 21 CFR Part 803; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.