Humanitarian Use Devices
Humanitarian Use Devices (HUDs) are a class of medical device for use in fewer than 4,000 individuals. Manufacturers may not profit from the sale of HUDs apart from the costs incurred to develop and test the device, except for devices indicated for pediatric use only. Because HUDs are not intended to be marketed to populations large enough to justify standard licensure requirements for other medical devices, FDA has alternate licensure requirements for HUDs.
To be approved for marketing, HUDs “must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.” This requirement expands options for patients who may benefit from a HUD that otherwise could not be brought to market while also providing an appropriate measure of safety for patients who, in consult with their care provider, elect to use a HUD.
However, insurance providers typically label Humanitarian Use Devices as “experimental” because their oversight by Institutional Review Boards indicates that consideration for using a HUD uses a protocol typically reserved for research.
NORD advocates for a regulatory framework that permits a functioning market for medical devices in small patient populations. While the relaxed standards for approval of HUD use is encouraging, unless manufacturers are able to recoup costs of developing devices for humanitarian use, the life-changing impact they have on patients with rare diseases will continue to be minimal. Read more about the Humanitarian Use Device Exemptions from FDA.