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    Pre-Approval Inspection

    FDA inspection of a manufacturing facility prior to PMA approval.

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

    Definition

    A Pre-Approval Inspection assesses whether the manufacturing site, processes, and quality systems are in a state of control sufficient to support PMA approval.

    What this means in practice

    PAI findings can delay or block PMA approvals. They also give FDA an early view into manufacturing capability.

    Cross-references

    Used by

    Things that build on this term.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2IMDRF/GHTF·1
    1. 1
      FDA Inspection Resources
      Verified
      FDAfda.gov
    2. 2
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org
    3. 3
      FDA - Device Manufacturing
      Verified
      FDAfda.gov

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