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Reporting Timeframes — 30-Day & 5-Day Reports

US-unique

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:

  1. The event requires remedial action to prevent an unreasonable risk of substantial harm to the public health; or
  2. 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 and serious injuries (to FDA); 5 working days for deaths if the importer becomes aware the device caused or contributed to the death

Counting the clock​

The MDR calendar starts on Day 0 — the date the manufacturer becomes aware of information suggesting a reportable event. Day For 30-day reports, the deadline is 30; for 5-day reports, the deadline end of the 5th working day (not including weekends or federal holidays). The must be received by FDA by the is the submission deadline.

Official resources​

The MDR clock starts when a manufacturer 'becomes aware' through any means—internal investigation, complaint hotline, field representatives, healthcare provider reports, or literature review. Manufacturers cannot intentionally delay the clock by deferring investigation. Once any employee with knowledge relevant to adverse events is informed, the clock begins, even if formal documentation is still pending.