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Post-Approval Studies for Medical Devices: Protocol Development, Tracking and Reporting Requirements

This guidance outlines procedures for handling Post-Approval Studies (PAS) imposed as conditions of PMA approval. It provides recommendations on protocol development, reporting requirements, study status tracking, and public disclosure of PAS information. The guidance aims to help stakeholders understand PAS requirements and facilitate timely completion of studies.

  1. Develop comprehensive PAS protocol including all recommended elements
  2. Submit protocol within required timeframe (30 days if not approved with PMA)
  3. Establish tracking system for enrollment milestones and reporting deadlines
  4. Submit enrollment status reports until enrollment completion
  5. Submit progress reports every 6 months until enrollment completion, then annually
  6. Notify FDA promptly of any challenges meeting milestones or requirements
  7. Submit final report within 3 months of study completion
  8. Maintain documentation of protocol adherence and study progress
  9. Monitor for safety signals and report any concerns promptly
  10. Prepare for public disclosure of study information on FDA website

Key Considerations

Clinical testing

  • Study protocol must include clear objectives, endpoints, population description, and follow-up schedule
  • Enrollment milestones recommended:
    • First subject within 6 months of protocol approval
    • 20% enrolled within 12 months
    • 50% enrolled within 18 months
    • 100% enrolled within 24 months

Safety

  • Safety concerns identified during PAS may lead to FDA actions including Safety Communications
  • Summary of safety data required in progress and final reports

Other considerations

  • 21 CFR 814.82: Post-approval requirements
  • 21 CFR 814.39: PMA supplements and amendments
  • 21 CFR 814.9: Confidentiality of data and information in PMA files
  • 21 CFR Part 20: Public information

Original guidance

  • Post-Approval Studies for Medical Devices: Protocol Development, Tracking and Reporting Requirements
  • HTML / PDF
  • Issue date: 2022-10-07
  • Last changed date: 2022-10-07
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: a395b01bb60bef23c505696e11a5aa63
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