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Pediatric Expertise for Advisory Panels Reviewing Medical Device Submissions

This guidance outlines procedures to ensure that FDA advisory panels reviewing premarket submissions or regulatory documents include or consult with pediatric experts when appropriate. It applies to all types of premarket submissions (PMA, PDP, 510(k), HDE, de novo applications, IDE) and other regulatory documents.

  1. Assess if pediatric expertise is needed based on the defined circumstances requiring pediatric input
  2. Consult with review division and management to confirm need for pediatric expertise
  3. Notify advisory panel executive secretary when pediatric expertise is required
  4. Ensure appropriate pediatric experts are available for panel deliberations
  5. Document pediatric expert participation as part of performance monitoring
  6. Consider alternative age ranges for pediatric populations based on specific device type if needed
  7. Utilize existing pediatric experts from FDA advisory committees across centers when appropriate

Key Considerations

Other considerations


Original guidance

  • Pediatric Expertise for Advisory Panels Reviewing Medical Device Submissions
  • HTML / PDF
  • Issue date: 2003-06-02
  • Last changed date: 2024-04-08
  • Status: FINAL
  • Official FDA topics: Medical Devices, Advisory Committees, Pediatric Product Development
  • ReguVirta summary file ID: 744423a2ad371033223279f2bc51189c
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