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Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type

This guidance provides recommendations for determining the type of regulatory submission required when modifying a PMA-approved Class III medical device. It covers changes to device design, labeling, manufacturing process, or manufacturing location that may affect safety and effectiveness. The guidance explains the decision-making process and criteria for selecting between different types of submissions: traditional PMA, panel-track supplement, 180-day supplement, real-time supplement, special PMA supplement, 30-day notice, manufacturing site change supplement, or periodic reports.

  1. Identify the modification and reason for change
  2. Conduct risk analysis to assess impact on safety and effectiveness
  3. Define required testing data to demonstrate continued safety and effectiveness:
    • Clinical data needs
    • Preclinical testing requirements
    • Manufacturing validation needs
  4. Select appropriate submission type based on:
    • Extent of clinical/preclinical data needed
    • Significance of the change
    • Impact on safety and effectiveness
    • Manufacturing considerations
  5. Prepare submission with:
    • Clear description of changes
    • Supporting test data
    • Risk analysis
    • Updated labeling if needed
  6. Consider consulting FDA before submission if unclear about appropriate pathway
  7. Monitor implementation and document changes according to quality system requirements
  8. Report minor changes in annual reports if no supplement needed

Key Considerations

Clinical testing

  • Substantial clinical data needed for panel-track supplements involving new indications or significant changes
  • Limited confirmatory clinical data may be needed for some 180-day supplements
  • No clinical data typically needed for real-time supplements

Non-clinical testing

  • New preclinical testing needed for traditional PMAs and 180-day supplements
  • Limited preclinical testing may be needed for panel-track supplements
  • Single discipline preclinical testing acceptable for real-time supplements

Software

  • Software modifications may require 180-day supplements if significant
  • Minor software changes may qualify for real-time supplements

Labeling

  • Significant labeling changes require 180-day supplements
  • Minor labeling changes may qualify for real-time supplements
  • Safety-enhancing labeling changes may use Special PMA Supplement - Changes Being Effected

Safety

  • Changes that enhance safety without affecting effectiveness may use Special PMA Supplement
  • Safety-related manufacturing changes may qualify for 30-day notice

Other considerations

  • IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety

Original guidance

  • Modifications to PMA-Approved Class III Medical Devices: Selecting the Appropriate Regulatory Submission Type
  • HTML / PDF
  • Issue date: 2008-12-11
  • Last changed date: 2022-02-08
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Premarket Approval (PMA), Biologics
  • ReguVirta summary file ID: 6ed6b419b5f1b628f51b76b9c507a326
This post is licensed under CC BY 4.0 by the author.