Benefit — FDA MDR reporting stance
Why the MDR 10-day / 30-day clock is a bright line
Missed or late user-facility MDR reports become their own enforcement matter. FDA distinguishes between "the device malfunctioned" (contestable) and "the user facility failed to report" (unconditional). Dated evidence of when you knew is the discipline that keeps the clock defensible.
The clock
- 10 working days — user facility MDR to manufacturer + FDA if device may have caused / contributed to a death
- 10 working days — user facility MDR to manufacturer if device may have caused / contributed to a serious injury (FDA notification only in specified cases)
- 30 calendar days — manufacturer MDR to FDA (parallel obligation)
- Annual report — user facility summary to FDA (21 CFR 803.33)
The clock starts when the facility "becomes aware." Dated independent evidence establishing exactly when that was becomes load-bearing.
Dollar frame
FDA Warning Letter for MDR failure: triggers public listing + facility-inspection escalation + follow-on device-clearance impact on all cleared products at facility.
Manufacturer recall involvement: hospitals that were slow to report + subsequently found in the manufacturer's user-facility list are named in the recall public docket. Reputational and follow-on-litigation implications.
Insurance coverage exclusions: some malpractice + product-liability carriers reserve rights when regulatory reporting was very late.
Who at your org cares
- Chief Compliance Officer — regulatory-reporting governance
- Risk Management — MDR intake + escalation workflow
- CMO / CMIO — clinical adverse-event awareness
- General Counsel — reporting-defense stance
- Biomedical Engineering / Device Governance — device inventory + AI-inclusive-device tracking
What "having it" looks like
Green: Snapshot timeline documents first-drift-day + severity trajectory. Risk Management uses that as the "date facility became aware" anchor. MDR filed within window. Documented stance defensible.
Red: No independent timeline. Vendor's dashboard was green until the vendor's own retrospective post-mortem. Regulator has room to argue actual awareness was earlier. Late-report penalty compounds the underlying issue.
$499. 3 business days.
Dated independent evidence of when the facility should reasonably have become aware. The MDR-clock anchor.
Buy $499