Office of Orphan Products Development

Who We Are The FDA Office of Orphan Products Development (OOPD) supports and advances the development and evaluation of new treatments for rare diseases. OOPD evaluates information from product sponsors to determine if drugs, biologics or medical devices meet the criteria for certain incentives and administers grants to provide funding for research on rare diseases. The office also works on rare disease issues with medical and research communities, professional organizations, academia, government agencies, industry and rare disease patient groups. What We Do - Work with sponsors to determine if their products meet the criteria for certain categories (e.g., orphan drug, rare pediatric disease drug or humanitarian use device designations). - Provide [orphan status to drugs and biologics](https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products "Designating an Orphan Product: Drugs and Biological Products") which are intended to treat, diagnose or prevent rare diseases that affect fewer than 200,000 people in the U.S. - Designate [medical devices](https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/humanitarian-use-device-hud-designation-program "Humanitarian Use Device (HUD) Designation Program") that intend to benefit patients in treating or diagnosing a disease or condition that affects fewer than 8,000 individuals in the U.S. per year. - Work with the [Office of Pediatric Therapeutics](https://www.fda.gov/about-fda/office-chief-medical-officer/office-pediatric-therapeutics "Office of Pediatric Therapeutics") and product centers to determine rare pediatric disease designation for drugs or biologics that meet certain criteria. Sponsors of such product applications may qualify for a priority review voucher, which can be redeemed to receive a priority review of a subsequent marketing application for a different product. - Award [grants](https://www.fda.gov/industry/grant-programs-support-development-medical-products-rare-diseases/orphan-products-grants-program "Orphan Products Grants Program") to provide funding for clinical trials and natural history studies that advance rare disease medical product development. - Award [grants](https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/pediatric-device-consortia-grants-program "Pediatric Device Consortia Grants Program ") that provide funding to develop nonprofit consortia to facilitate pediatric medical device development. - Awards grants and contracts to use in the development of tools, methods and processes to characterize the natural history of [rare neurodegenerative diseases](https://www.fda.gov/industry/grant-programs-support-development-medical-products-rare-diseases/fda-rare-neurodegenerative-disease-grants-program "FDA Rare Neurodegenerative Disease Grants Program"), to identify molecular targets for these diseases, and to increase efficiency and productivity of new treatment development.