All terms
Medical Device Reporting (FDA)
FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
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. What the regulation says
Under 21 CFR Part 803, manufacturers, importers, and device user facilities have specific obligations to report adverse events related to medical devices to the FDA. These reports include deaths, serious injuries, and certain malfunctions, each with defined reporting timeframes and submission requirements, ensuring post-market surveillance.What this means in practice
Not to be confused with the EU Medical Device Regulation. FDA MDR data is publicly searchable through the MAUDE database.Examples
- A hospital, as a user facility, reports a patient death potentially caused by a ventilator malfunction to the FDA within 10 working days, as required by 21 CFR 803.30.
- A manufacturer submits a 5-day report to the FDA after discovering a serious injury associated with one of their surgical devices that required immediate remedial action to prevent further harm, per 21 CFR 803.53.
- An importer identifies a pattern of malfunctions in an imaging device that could lead to serious injury and submits an MDR to the FDA within 30 calendar days, adhering to 21 CFR 803.40.
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.
Frequently asked questions
The primary purpose is to enable the FDA to monitor device performance, detect potential safety issues, and take appropriate actions to protect public health.
Cross-references
See also
Related terms
Shared paths + categoryPost-Market
Medical Device Vigilance
Reporting and management of serious incidents and field safety corrective actions.
Post-Market Mastery
Post-Market
Post-Market Surveillance(PMS)
Activities to monitor device safety and performance after market release.
Post-Market Mastery
Post-Market
Medical Device Recall
Removal or correction of a marketed device that violates FDA law.
Post-Market Mastery · adjacent
Quality & Risk
Complaint Handling
Process for receiving, evaluating, and responding to device complaints.
Post-Market Mastery · adjacent
Post-Market
Field Safety Corrective Action(FSCA)
Action taken to reduce a risk of serious deterioration in health associated with a device.
Post-Market Mastery
Post-Market
Periodic Safety Update Report(PSUR)
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
Post-Market Mastery
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
eCFR·1FDA·2
- 121 CFR Part 803VerifiedeCFRecfr.gov
- 2MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
- 3FDA Recalls - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.