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    Lot Traceability

    Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number.

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

    Definition

    21 CFR 820.65 requires traceability for devices intended for surgical implant or whose failure could cause significant injury. Lot traceability links UDI-PI to inputs, processes, and finished-goods distribution records.

    What this means in practice

    Effective traceability is the difference between scoping a recall to a few lots versus the entire installed base.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    eCFR·1ISO·1IMDRF/GHTF·1
    1. 1
      21 CFR 820.65
      Verified
      eCFRecfr.gov
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org

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