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Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements

This guidance explains when a PMA supplement should be submitted for manufacturing site changes (including processing, packaging, or sterilization site) of PMA-approved devices. It also outlines the documentation requirements and factors FDA considers when determining if a pre-approval inspection is necessary. The guidance applies only to devices with approved PMA, product development protocol, or HDE, and does not cover 510(k) devices, De Novo devices, or IDE devices.

  1. Determine if change requires site change supplement or 30-day notice based on guidance criteria
  2. Prepare required documentation package including:
    • Device and site change descriptions
    • Manufacturing diagrams and flows
    • Process validation plans
    • Control procedures
    • Supplier documentation if applicable
  3. Assess likelihood of pre-approval inspection based on FDA factors
  4. Complete all validation activities before potential inspection
  5. Submit appropriate supplement type with complete documentation
  6. Wait for FDA approval before implementing site change
  7. Maintain compliance with QS regulation requirements throughout process

Key Considerations

Non-clinical testing

  • Process validation or revalidation master plan and procedures must be provided
  • Validation reports should be submitted when available
  • All validation activities should be completed before inspection scheduling

Software

  • Validation of software used in production or quality system where applicable must be documented

Safety

  • Environmental and contamination control procedures must be provided if conditions could affect device safety
  • Inspection, measuring and test equipment calibration procedures must be documented
  • Incoming and final acceptance activities procedures must be provided

Other considerations

  • 21 CFR Part 820: Quality System Regulation
  • 21 CFR 814.39: PMA Supplements and Amendments
  • 21 CFR 807.3: Establishment Registration and Device Listing

Original guidance

  • Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
  • HTML / PDF
  • Issue date: 2018-12-17
  • Last changed date: 2020-10-22
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket, Premarket Approval (PMA), Biologics
  • ReguVirta summary file ID: a62ca8e2ed16fcf68dcf26da22be8ab8
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