Pediatric Device Consortia Grants Program (P50)

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 generation of devices. In addition, consortia should also provide expertise on evidence generation, including use of real world evidence, for pediatric device development.The pediatric population (i.e., neonates, infants, children, and adolescents) for medical devices is defined as individuals who are younger than 22 years of age (that is, from birth through the twenty-first year of life not including the twenty-second birthday) at the time of diagnosis or treatment.