September 11, 2023- 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.
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.