Humanitarian Device Exemption

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. Generally, these are known as orphan devices. The FDA calls such a device approved in this manner a "Humanitarian Use Device".

Requirements

To qualify, the device must be intended to benefit patients with a rare disease or condition. 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.