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Premarket Assessment of Medical Devices for Pediatric Use

This guidance provides recommendations for the premarket assessment of medical devices intended for use in pediatric populations (birth through 21 years of age). It aims to help define pediatric populations, identify information needed for safety and effectiveness evaluation, and outline protections for pediatric subjects in clinical trials.

  1. Define target pediatric subgroups clearly based on age, size, and development
  2. Conduct comprehensive risk assessment for each pediatric subgroup
  3. Determine if clinical data needed or if bench/animal testing sufficient
  4. Ensure appropriate pediatric expertise available throughout development
  5. Design age-appropriate human factors testing
  6. Develop clear labeling with subgroup-specific information
  7. Include pediatric-specific warnings and precautions
  8. Establish appropriate consent/assent procedures for clinical studies
  9. Ensure clinical sites have pediatric-specific equipment and expertise
  10. Document justification if excluding certain pediatric subgroups

Key Considerations

Clinical testing

  • Clinical data may be needed when:
    • Pre-clinical data inadequate to establish safety/effectiveness
    • Adult data inadequate to predict pediatric risks
    • Design modifications need validation
    • Age-appropriate treatment regimen needed
  • Consider including pediatric patients in original device studies
  • Study design must include appropriate pediatric expertise and emergency measures
  • Special protections required for pediatric subjects

Non-clinical testing

  • Bench and animal testing may be sufficient in some cases
  • Pre-clinical testing varies by device type
  • Risk assessment and mitigation methods needed
  • Consider anatomical and physiological differences from adults

Human Factors

  • Consider age-appropriate usability
  • Assess manual dexterity and strength requirements
  • Evaluate clarity of user interface
  • Account for different maturity levels
  • Consider resistance to wear and tear
  • Evaluate portability needs

Labeling

  • Clearly define intended pediatric subgroups
  • Include specific age ranges rather than broad “pediatric” term
  • Address risks specific to pediatric subgroups
  • Provide clear instructions considering different age groups
  • Include adverse events by pediatric subgroup
  • Describe study results by age group

Biocompatibility

  • Consider toxicity and carcinogenicity
  • Account for immune system maturity
  • Evaluate hormonal influences

Safety

  • Consider growth and development impacts
  • Assess short and long-term effects
  • Account for activity levels
  • Include pediatric-specific emergency measures
  • Evaluate impact on organ systems

Other considerations

  • ISO 10993-6:2007: Biological Evaluation of Medical Devices

Original guidance

  • Premarket Assessment of Medical Devices for Pediatric Use
  • HTML / PDF
  • Issue date: 2014-03-24
  • Last changed date: 2024-04-11
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Pediatric Product Development, Biologics
  • ReguVirta summary file ID: 61b2acd953fa247bfb6fce7fe72394d7
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