Pediatric Device Consortia (PDC) Grants Program

Pediatric Device Consortia Grants Program

Funds nonprofit pediatric device consortia building infrastructure for regulatory and development progress.

The FDA Pediatric Device Consortia (PDC) Grants Program funds nonprofit consortia that deliver regulatory advisory, business planning, and device development services to innovators working on medical devices for pediatric patients. The program was first authorised under the Pediatric Medical Device Safety and Improvement Act of 2007 and was most recently reauthorised through FY2027 by the Food and Drug Omnibus Reform Act of 2022 (FDORA). The annual program budget is approximately $6 million. In FY2023, FDA funded five consortia under RFA-FD-23-024: the Southwest National Pediatric Device Consortium, the UCSF-Stanford Pediatric Device Consortium, the Consortium for Technology and Innovation in Pediatrics (CTIP 3.0), the Alliance for Pediatric Device Innovation, and the Midwest Pediatric Device Consortium. These consortia provide services including intellectual property advising, prototyping, engineering support, laboratory testing, grant-writing assistance, and direct sub-awards to device innovators.

Eligibility under the PDC program is restricted to nonprofit organisations; for-profit companies, individuals, and universities may participate as consortium members or receive sub-awards, but may not serve as the primary applicant to FDA. Applications route through grants.gov via the applicable RFA-FD cycle. The FY2023 award cycle (RFA-FD-23-024) has concluded. The next RFA is anticipated before the FY2027 authorization expiry under FDORA 2022, but no specific dates are confirmed. Device developers and entrepreneurs seeking support for pediatric device projects should contact existing PDC consortium members directly rather than applying to FDA.

The five currently funded consortia operate as regional platforms, each serving a distinct geographic cluster of innovators with a mix of advising, prototyping, and sub-award funding. Pediatric device development faces unique regulatory and commercial challenges because children differ from adults in size, physiology, growth, and disease propensity, and the labeled pediatric device market remains small relative to adult devices. PDC consortia address this gap by building shared infrastructure that reduces cost and regulatory risk for individual innovators, improving clinical trial readiness and advancing the pipeline of FDA-cleared devices for pediatric use.