humanitarian device exemption (HDE)

Is a status granted by the Food and Drug Administration (FDA) to devices intended for treatment or diagnosis of a disease or condition that affects no more than 8,000 individuals in the United States per year. This status indicates that the FDA has granted an exemption from the effectiveness requirements of the Food, Drug, and Cosmetic Act. The device manufacturer is still required to provide sufficient information for the FDA to determine that the device does not pose unreasonable or significant risks and that the probable benefit outweighs the risks, in comparison to the probable risks and benefits of currently available devices or alternative forms of treatment. HDE status provides an incentive for the development of devices for use in limited populations. Clinical use of investigational devices with HDE status is not considered to be research but the FDA nonetheless requires IRB review prior to use. See also: humanitarian use device