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.
What You Need to Know? 👇
What are the FDA-defined pediatric age subgroups for medical device development?
FDA defines four pediatric subgroups: newborn (birth to 1 month), infant (>1 month to 2 years), child (>2 to 12 years), and adolescent (>12 through 21 years). Additional subpopulations include low birth weight (<2.5 kg) and very low birth weight (<1.5 kg) newborns.
When is clinical data required for pediatric medical devices?
Clinical data is required when pre-clinical testing is inadequate to establish safety and effectiveness, adult data cannot predict pediatric risks, pediatric data is needed for design modifications validation, or to develop age-appropriate treatment regimens for the intended pediatric population.
What unique host characteristics must be considered for pediatric device design?
Key characteristics include age-appropriate sizing, growth and development impact, body habitus variations, developmental milestones, pathophysiology differences, behavioral factors, psychosocial considerations, human factors engineering, and surgical factors for implantable devices. Weight and physiological development often matter more than chronological age.
What are the IRB requirements for pediatric device clinical trials?
IRBs must classify pediatric research into four risk-benefit categories, ensure adequate provisions for obtaining parental permission and child assent, determine appropriate safeguards, and verify that pediatric expertise and emergency equipment are available. Additional protections apply under 21 CFR Part 50 Subpart D.
How should pediatric device labeling differ from adult device labeling?
Pediatric labeling must specify relevant age ranges rather than broad “pediatric” terms, include age-specific contraindications and warnings, report adverse events by pediatric subgroups, provide clear instructions considering developmental factors, and address special considerations like growth impact and activity restrictions.
What is the least burdensome approach for pediatric device approval?
The least burdensome approach involves using existing adult data when applicable, conducting risk assessments to identify necessary studies, utilizing pre-submission meetings with FDA, considering alternative data sources like literature, and designing studies that gather adequate data while minimizing subject burden and risk.
What You Need to Do 👇
Recommended Actions
- Define target pediatric subgroups clearly based on age, size, and development
- Conduct comprehensive risk assessment for each pediatric subgroup
- Determine if clinical data needed or if bench/animal testing sufficient
- Ensure appropriate pediatric expertise available throughout development
- Design age-appropriate human factors testing
- Develop clear labeling with subgroup-specific information
- Include pediatric-specific warnings and precautions
- Establish appropriate consent/assent procedures for clinical studies
- Ensure clinical sites have pediatric-specific equipment and expertise
- 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
- Account for behavioral and psychosocial factors
- Consider family structure and environment
- Evaluate surgical factors for implants
- Assess impact on developmental milestones
Relevant Guidances đź”—
- Design Controls for Medical Device Manufacturers
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Content of Premarket Submissions for Device Software Functions
- Benefit-Risk Determinations for Medical Device Premarket Review
Related references and norms đź“‚
- ISO 10993-6:2007: Biological Evaluation of Medical Devices