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.
What You Need to Know? 👇
What are the pediatric age ranges defined by FDA for medical device advisory panels?
FDA defines pediatric subpopulations as: newborn (birth to 1 month), infant (1 month to 2 years), child (2 to 12 years), and adolescent (12-21 years). These ranges guide when pediatric expertise is needed for device reviews.
When must FDA advisory panels include pediatric experts for medical device reviews?
Pediatric expertise is required when devices have pediatric indications, include pediatric study data, may support future pediatric use, need pediatric study design input, or when panels may discuss potential pediatric applications.
Does the pediatric expertise requirement apply only to PMA applications?
No, while MDUFMA amended PMA requirements, FDA applies pediatric expertise to all premarket submissions including 510(k), HDE, de novo applications, IDE, and guidance document reviews when pediatric populations may be affected.
How does FDA ensure pediatric experts are available for advisory panels?
FDA maintains a cadre of special government employees with pediatric expertise across 18 advisory panels and recruits through pediatric professional associations, current SGEs, and industry stakeholders to ensure readiness.
Who determines if pediatric expertise is needed for a specific device review?
The review team leader determines the need by conferring with division management, ODE/OIVD leadership, applicants, and advisory panel members, then advises the executive secretary to arrange appropriate pediatric consultation.
How does FDA monitor compliance with pediatric expertise requirements?
FDA tracks availability of pediatric experts through Performance Scorecards using the “Panel Readiness Index” measurement in both the Office of Device Evaluation and Office of In Vitro Diagnostic Device Evaluation and Safety.
What You Need to Do 👇
Recommended Actions
- Assess if pediatric expertise is needed based on the defined circumstances requiring pediatric input
- Consult with review division and management to confirm need for pediatric expertise
- Notify advisory panel executive secretary when pediatric expertise is required
- Ensure appropriate pediatric experts are available for panel deliberations
- Document pediatric expert participation as part of performance monitoring
- Consider alternative age ranges for pediatric populations based on specific device type if needed
- Utilize existing pediatric experts from FDA advisory committees across centers when appropriate
Key Considerations
Other considerations
- Pediatric expertise is required when:
- Device has labeled indications for pediatric subpopulations
- Study data includes pediatric subpopulations
- Adult data may support future pediatric indications
- Input needed on pediatric study design/protocol
- Potential pediatric use may be discussed
- Pediatric subpopulations are defined as:
- Newborn: birth to 1 month
- Infant: 1 month to 2 years
- Child: 2 to 12 years
- Adolescent: 12-21 years
Relevant Guidances 🔗
- Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
- Premarket Assessment of Medical Devices for Pediatric Use
- Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications