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    Device Master Record

    Compilation of records containing the procedures and specifications for a finished device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Per 21 CFR 820.181, the Device Master Record (DMR) includes device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation/maintenance procedures.

    What this means in practice

    The DMR is the source of truth for manufacturing. Inadequate DMR control is a common source of FDA Form 483 observations.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    eCFR·1IMDRF/GHTF·1FDA·1
    1. 1
      21 CFR 820.181
      Needs review
      eCFRecfr.gov
    2. 2
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org
    3. 3
      FDA - Device Manufacturing
      Verified
      FDAfda.gov

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