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    Device History Record

    Records demonstrating that a device is manufactured per the DMR.

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

    Definition

    Per 21 CFR 820.184, the Device History Record (DHR) contains the production records of a specific batch, lot, or unit of finished device, providing traceability of materials, process steps, and inspections.

    What this means in practice

    DHR completeness is an early indicator of manufacturing process control during inspections.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    eCFR·1FDA·1ISO·1
    1. 1
      21 CFR 820.184
      Needs review
      eCFRecfr.gov
    2. 2
      FDA - Device Manufacturing
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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