Pediatric medical device development faces unique challenges as children often differ from adults in size, growth, development, body chemistry, and disease propensity. Due in part to these issues, only a small number of medical devices approved are labeled for pediatric use.
To address this health inequity, FDA funds the Pediatric Device Consortia (PDC) grants program to advance pediatric medical device development. These nonprofit consortia provide a platform of experienced regulatory, business planning, and device development services such as intellectual property advising, prototyping, engineering, laboratory testing, and grant- writing, to foster advancement of medical devices for pediatric patients. In addition to key advising services, the consortia also provide critical funding to innovators to directly advance these projects.
The Food and Drug Omnibus Reform Act of 2022 reauthorized the PDC for fiscal years 2023 through 2027.
Funded Pediatric Device Consortia
In FY 2023, FDA funded a range of consortia to support pediatric medical device development. These awards include commitments to improving clinical trial infrastructure, advancing diversity and health equity as well as real-world evidence projects:
- Southwest National Pediatric Device Consortium (SWPDC)
- UCSF- Stanford Pediatric Device Consortium
- The Consortium for Technology & Innovation in Pediatrics: CTIP 3.0
- Alliance for Pediatric Device Innovation
- Midwest Pediatric Device Consortium (MPDC)
- CDRH Pediatric Medical Devices
- Device Advice: Comprehensive Regulatory Assistance
- CDRH Learn: Online educational modules intended to provide information about medical device laws, regulations, and policies
- How to Study and Market your Device
- Guide to NIH Funding Opportunities
- SBIR/STTR Funding: Federal Business Opportunities