A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness. The FDA calls a device approved in this manner a "Humanitarian Use Device" (HUD).
Requirements
To qualify, the device must be intended to benefit patients with a rare disease or condition (i.e. fewer than 8,000 people in the US annually).[1][2] The applicant must also show that there is no other way, that the device could be brought to market, and that there is no comparable device already available.[3]