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    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 September 19, 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. 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.
    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.

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1FDA·2
    1. 1
      21 CFR Part 803
      Tier 1 Verified
      eCFRecfr.gov
    2. 2
      MAUDE Database
      Tier 2 Verified
      FDAaccessdata.fda.gov
    3. 3
      FDA Recalls - Medical Devices
      Tier 2 Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.