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U.S. Department of Health and Human Services

For Industry

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Office of Orphan Products Development Designates 200th Humanitarian Use Device

The Office of Orphan Products Development (OOPD) recently designated its 200th humanitarian use device (HUD) designation request. The HUD designation program was created to provide incentives for the development of medical devices that treat or diagnose a rare disease or condition, which is defined as a disease or condition that affects fewer than 4,000 new patients per year. 

Since the program's inception in 1996, OOPD has received over 300 HUD requests, designated 200, and ultimately approved over 55 devices for rare diseases and conditions.