Comments Sought on HUD Requirements Extension

Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Humanitarian Use Devices (HUDs) — 21 CFR 814.” Under FDA regulations, the agency is authorized to exempt a HUD from effectiveness requirements provided that the device: (1) Is designed to treat or diagnose a disease or condition that affects no more than 8,000 individuals in the U.S.; (2) would not be available to a person with a disease or condition unless an exemption is granted and there is no comparable device other than another HUD approved under this exemption that is available to treat or diagnose such disease or condition; and (3) will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use.