Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional

The intended goal of this FOA is to facilitate the development, production, and distribution of pediatric medical devices. Although the FOA is issued by the FDA's Office of Orphan Products Development, the grant application is intended to encompass devices for all pediatric diseases and conditions, not just those that are rare. Applicants will request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices. The advising and services will focus on the total product life cycle for medical devices from concept, through pre-market development, to commercialization, and replacement by subsequent generations of devices. In addition, consortia should also provide expertise on evidence generation, including use of real-world evidence (RWE), for pediatric device development. As the consortia execute their mission, they are encouraged to collaborate with each other and the broader community and to maintain a commitment to health equity, diversity, and inclusion to foster innovation, development, and improve access to medical devices for all pediatric patients. Pediatric medical devices treat or diagnose diseases and conditions in individuals who are 21 years of age or younger (that is, up to but not including the 22nd birthday) at the time of diagnosis or treatment (21 CFR 814.3(s)).