It’s the Hard-Knock Life for Orphan Devices: A History of the FDA’s Humanitarian Device Exemption Program

Ray Wanderman Lefco


Humanitarian Use Devices (HUDs) are medical devices intended to benefit patients in the treatment or diagnosis of rare diseases or conditions. Although HUDs are Class III products normally subject to premarket approval (PMA), medical device manufacturers may apply for a Humanitarian Device Exemption (HDE) that exempts qualified HUDs from the effectiveness requirements of sections 514 and 515 of the Federal Food, Drug, and Cosmetic Act (FDCA) and subjects them to certain profit and use restrictions. This Article traces the historical development of the HDE and discusses its impact in light of that history.