Reporting Timeframes — 30-Day & 5-Day Reports
The US 5-day MDR report for urgent safety issues is more stringent than equivalent obligations in many other jurisdictions.
30-Day reports (standard timeframe)
Manufacturers must submit MDRs within 30 calendar days after becoming aware that a device may have caused or contributed to a death or serious injury, or that a malfunction occurred that would likely cause or contribute to a death or serious injury if it recurred.
The 30-day clock starts from the date the manufacturer receives or becomes aware of information suggesting a reportable event — not from the date of the event itself.
5-Day reports (urgent safety situations)
Manufacturers must submit an MDR within 5 work days when:
- The event requires remedial action to prevent an unreasonable risk of substantial harm to the public health; or
- FDA has made a written request for 5-day reporting for the type of event involved
5-day reports are used for serious safety issues where rapid FDA notification is critical — such as when a field safety corrective action (recall) is being initiated concurrently.
Supplemental MDR reports
If information becomes available after an initial 30-day or 5-day report, a supplemental report (30-day follow-up) must be submitted within 30 days of receiving the new information.
User facility and importer timeframes
- User facilities: 10 working days for deaths and serious injuries
- Importers: 30 calendar days for deaths (to FDA and manufacturer); serious injuries to manufacturer within 30 days
Counting the clock
The MDR calendar starts on Day 0 — the date the manufacturer becomes aware of information suggesting a reportable event. Day 30 (or Day 5) is the submission deadline.