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Manufacturing and Supply Chain Changes for PMA and HDE Devices During Public Health Emergency

This guidance applies to limited modifications made to devices approved through PMA or HDE programs that would normally require a supplement or 30-day notice submission to FDA. It specifically addresses modifications needed to: - Address component unavailability due to supply chain disruptions - Accommodate manufacturing changes for social distancing - Change manufacturing facilities - Modify packaging procedures

  1. Evaluate if planned modifications fall within scope of guidance
  2. Document rationale for changes related to manufacturing limitations or supply chain issues
  3. Implement quality system controls for changes per 21 CFR Part 820
  4. Verify changes don’t negatively impact safety or performance
  5. Maintain complete documentation of changes and testing
  6. For facility changes, verify acceptable GMP history
  7. Include modifications in next periodic report to FDA
  8. Monitor FDA updates to this policy
  9. Ensure changes outside policy scope follow normal supplement submission requirements

Key Considerations

Non-clinical testing

  • Manufacturers must verify changes to confirm they don’t negatively affect safety or performance
  • Documentation of functional testing may be required
  • Documentation of mechanical testing (drop, vibration) may be required
  • Documentation of temperature testing may be required

Labelling

  • Changes to labeling outside the scope of manufacturing modifications are not covered by this policy

Software

  • Software/firmware modifications to accommodate component changes must be documented and verified
  • Software changes that don’t impact finished device performance may be allowed

Safety

  • Changes must not affect device safety
  • Changes to sterility assurance level (SAL) or sterilization method are not covered
  • Changes to reduce quality control testing are not covered

Other considerations

  • ISO 13485: Medical devices - Quality management systems for regulatory purposes

Original guidance

  • Manufacturing and Supply Chain Changes for PMA and HDE Devices During Public Health Emergency
  • HTML / PDF
  • Issue date: 2023-11-02
  • Last changed date: 2023-11-01
  • Status: FINAL
  • Official FDA topics: Medical Devices, HUD/HDE, Premarket Approval (PMA), Biologics
  • ReguVirta summary file ID: 4661ceaa7390c0adfe88801ee8a24360
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