Post-Market
Medical Device Reporting (FDA)(MDR)
In one line
FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Definition
Medical Device Reporting under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to report device-related deaths, serious injuries, and certain malfunctions to FDA within defined timeframes.
Manufacturers must file a 30-day report for deaths, serious injuries and malfunctions that would likely cause or contribute to death or serious injury if they recurred, and a 5-day report when remedial action is needed to prevent unreasonable risk or FDA requests it. User facilities report deaths to FDA and the manufacturer and serious injuries to the manufacturer. FDA publishes reports in the MAUDE database, and some malfunctions qualify for quarterly summary reporting under the VMSR program.
Why it matters
Not to be confused with the EU Medical Device Regulation. FDA MDR data is publicly searchable through the MAUDE database.
Common pitfalls
- •Failing to distinguish between reportable malfunctions and those that do not meet the criteria for Medical Device Reporting can lead to non-compliance.
- •Delaying the submission of a report due to incomplete information, rather than submitting a timely initial report with a follow-up, is a common pitfall.
- •Not adequately training personnel on the criteria and procedures for identifying and reporting adverse events can result in missed reports.
- •Confusing the reporting requirements for manufacturers with those for user facilities or importers can lead to incorrect submissions.
- •Underreporting subtle device malfunctions that, if recurrent, could escalate to serious harm is a significant oversight.
Sources
- 21 CFR Part 803 · eCFR
- MAUDE Database · FDA
- FDA Recalls - Medical Devices · FDA