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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 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 this means in practice

    Not to be confused with the EU Medical Device Regulation. FDA MDR data is publicly searchable through the MAUDE database.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    eCFR·1FDA·2
    1. 1
      21 CFR Part 803
      Verified
      eCFRecfr.gov
    2. 2
      MAUDE Database
      Verified
      FDAaccessdata.fda.gov
    3. 3
      FDA Recalls - Medical Devices
      Verified
      FDAfda.gov

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