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" (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]

See also

• Federal Food, Drug, and Cosmetic Act
• Premarket approval