FDA Office of Orphan Products Development

Funds rare disease treatment development by supporting clinical studies, natural history research, and pediatric medical device development.

The FDA Office of Orphan Products Development is a federal office inside the US Food and Drug Administration and the Department of Health and Human Services. It funds clinical research for rare diseases, defined here as conditions affecting fewer than 200,000 people in the United States, and its annual grant budget is about USD 23 million.

The office runs three grant programs: Orphan Products Grants, Rare Neurodegenerative Disease Grants, and Pediatric Device Consortia Grants. Those routes support clinical trials, natural history studies, ALS and other rare neurodegeneration projects, and the infrastructure needed to develop pediatric devices. Applications move through grants.gov and the NIH-style RFA-FD series, which keeps the process close to the broader federal research-grants system.

OOPD is a good fit for teams that can work in a regulated clinical environment and document unmet need clearly. Its strongest applicants usually pair a defined patient population with a protocol, device concept, or evidence package that can survive FDA review. The office also sits next to orphan drug and rare-pediatric incentive programs, but its funding role is specifically the grant channel that advances rare-disease evidence and device development.