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Use of Published Literature and Previously Submitted Data in PMA Supplements for Class III Medical Devices

This guidance clarifies requirements for Class III medical device PMA supplements, focusing on three main areas: 1. Use of published literature as supporting evidence 2. Recognition of previously submitted data to avoid duplication 3. Priority review eligibility criteria

  1. When using published literature:
    • Ensure sufficient device design/performance details are available
    • Verify comparability between published device and supplement device
    • Obtain underlying data when possible
    • Document multiple independent studies with consistent findings
  2. For data requirements:
    • Review existing PMA/PDP/HDE data for relevance
    • Only submit new data necessary to support the change
    • Justify use of previously submitted data
  3. For priority review:
    • Determine if the supplement provides significant public health benefits
    • Follow updated CDRH policy for expedited review requirements
  4. Maintain detailed documentation of:
    • Clinical protocols and amendments
    • Statistical analysis plans
    • Complete patient accounting
    • Adverse event information

Key Considerations

Clinical testing

  • Clinical data detail level should match 21 CFR 814.20(b)(6)(2) requirements including:
    • Number of investigators and subjects
    • Selection/exclusion criteria
    • Safety and effectiveness data
    • Adverse reactions and complications
    • Patient discontinuation and complaints
    • Device failures and replacements
    • Statistical analyses

Safety

  • Complete safety information must be provided for all patients who died or discontinued
  • Adverse events from literature should be considered alongside original PMA/PDP/HDE adverse events
  • New indications may require additional safety assessment if presenting new risks

Other considerations

  • 21 CFR 814.20: PMA requirements
  • 21 CFR 860.7: Valid scientific evidence requirements
  • 21 CFR 814.39: PMA supplement requirements

Original guidance

  • Use of Published Literature and Previously Submitted Data in PMA Supplements for Class III Medical Devices
  • HTML
  • Issue date: 1998-05-19
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 1d6f00c9aac4f855fd693766c251af89
This post is licensed under CC BY 4.0 by the author.