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Uniform Inspection Process and Communications for Medical Device Establishments

This guidance outlines FDA's uniform processes and standards for device establishment inspections (excluding for-cause inspections) of both foreign and domestic facilities. It specifically addresses pre-announcement procedures, inspection timeframes, and communication standards during inspections.

  1. Establish internal procedures for receiving and managing FDA inspection pre-announcements
  2. Develop a protocol for managing inspection communications and documentation
  3. Create a checklist for inspection preparation based on standard timeframes
  4. Train relevant staff on the inspection process and communication requirements
  5. Implement a system to track and document all inspection-related communications
  6. Prepare templates for recording daily inspection observations and discussions
  7. Establish procedures for handling potential inspection timeframe extensions
  8. Create a process for managing and responding to requests for advance records review

Key Considerations

Other considerations

  • Pre-announcement of inspections required:
    • Domestic inspections: minimum 5 calendar days notice
    • Foreign inspections: more than 5 calendar days notice
  • Standard inspection timeframe: 3-6 continuous business days
  • Regular communication requirements during inspection:
    • Daily discussions of observations when possible
    • Verbal communication of inspection status
    • Recording of communications allowed with mutual consent
  • Pre-announcement should include:
    • Type and nature of inspection
    • Planned timeframe and duration
    • Advance notice of records that may be requested
  • No specific norms or ISO standards referenced in this guidance

Original guidance

  • Uniform Inspection Process and Communications for Medical Device Establishments
  • HTML / PDF
  • Issue date: 2020-06-29
  • Last changed date: 2024-11-05
  • Status: FINAL
  • Official FDA topics: Medical Devices, Administrative / Procedural, Biologics
  • ReguVirta summary file ID: 1f22bcc7cc58a929a75fb635cb700896
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