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Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A

This guidance describes how to compile and submit readily available pediatric use information for medical devices in premarket submissions (PMAs, HDEs, PDPs) as required by Section 515A of the FD&C Act. It applies to submissions made on or after April 10, 2014, and covers pediatric patients aged 21 years or younger.

  1. Create a dedicated “515A Pediatric Device Use Information” section in the submission
  2. Conduct thorough literature search using acceptable public sources to gather pediatric use information
  3. Document search methodology and criteria used for source selection
  4. Present information in tabular format including:
    • Indication for use
    • Pediatric incidence/prevalence
    • Affected subpopulations
    • Device components applicable to pediatric use
    • Data sources
  5. Include narrative summary of disease/condition natural history in pediatric populations
  6. Ensure no proprietary or confidential information is included in pediatric use section
  7. For supplements, provide any new pediatric information or reference previous submission
  8. Consider whether special considerations apply for older adolescents (18-21 years)
  9. Consult FDA review division if planning to pursue specific pediatric indications, as additional data may be needed

Key Considerations

Labelling

  • Information about pediatric use should be included in a separate section titled “515A Pediatric Device Use Information”
  • Should include description of device uses and estimates of affected pediatric patients
  • May need warnings or contraindications for pediatric use if evidence suggests potential harm

Other considerations


Original guidance

  • Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
  • HTML / PDF
  • Issue date: 2014-05-01
  • Last changed date: 2024-04-08
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Pediatric Product Development, Biologics
  • ReguVirta summary file ID: 3092baee8c72f2704c8dc388a38f5b74
This post is licensed under CC BY 4.0 by the author.