Pediatric Device Consortia Grant Program (P50)

This FOA, issued by FDA, Office of Orphan Products Development, Pediatric Devices Consortia, solicits grant applications from nonprofit consortia to facilitate the development, production, and distribution of pediatric medical devices. While the pediatric device consortia are non-profit entities, their contacts and membership can include for-profit partners. FDA will provide grants to consortia which provide expert advising and support services to innovators of children's devices. These services should include business and regulatory consulting, as well as device testing capabilities. This program is intended to further the development of multiple pediatric devices; thus, grants are not awarded to support the development of a single device project. Although administered by the Office of Orphan Products Development, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.