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30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices

This guidance clarifies what manufacturing method or process changes qualify for submission as 30-day notices versus other types of submissions (135-day PMA supplements or 75-day HDE supplements) for devices with approved PMAs or HDEs. It provides details on the content requirements and submission process for these notices.

  1. Determine if manufacturing change qualifies for 30-day notice versus other submission types
  2. Prepare complete submission package including:
    • Clear identification as 30-day notice
    • Description of change and rationale
    • Validation data summary
    • Quality system compliance statement
    • Process monitoring procedures
    • Supplier controls if applicable
  3. Submit electronic copy with paper cover letter and applicable user fee
  4. Wait 30 days before implementing change unless FDA indicates inadequacy
  5. If FDA deems notice inadequate, prepare 135-day PMA or 75-day HDE supplement as directed
  6. Document changes in annual report if they do not affect safety or effectiveness
  7. Maintain all validation data and quality system records related to the change
  8. Monitor implemented changes through routine quality system procedures

Key Considerations

Non-clinical testing

  • Validation studies must be completed to demonstrate the manufacturing change does not significantly impact device operation
  • Statistical rationale for sampling methods must be provided
  • Test data analysis using valid statistical methods required

Labelling

  • Labeling changes combined with manufacturing changes require 180-day PMA or 75-day HDE supplement instead of 30-day notice

Safety

  • Changes must not affect device safety and effectiveness
  • Quality control and process monitoring procedures must be established
  • Purchasing controls required for new suppliers of critical components

Other considerations

  • ISO 14644: Cleanrooms and associated controlled environments
  • 21 CFR 820: Quality System Regulation

Original guidance

  • 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
  • HTML / PDF
  • Issue date: 2019-12-16
  • Last changed date: 2021-01-26
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket Approval (PMA), Device & Drug Safety, Premarket, Biologics, HUD/HDE, Administrative / Procedural
  • ReguVirta summary file ID: b484e27f5b2a62b0527ed8720b7a8224
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