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  1. Medical products for rare diseases and conditions

Pediatric Device Consortia Grants Program

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, of which, some are designed specifically for children and others are adapted from adult applications. 

To address this health inequity, FDA funds the Pediatric Device Consortia (PDC) grants program to advance development of medical devices for children. These nonprofit consortia provide a platform of experienced regulatory, business planning, and device development services such as intellectual property advising, prototyping, engineering, laboratory and animal 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

FDA has funded a range of consortia to support pediatric medical device development including:

See the 2018 announcement for more information and Pediatric Device Consortia Grants Awarded for historical awards.

Additional resources

 



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