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.
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:
- 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
Original guidance
This post is licensed under CC BY 4.0 by the author.