A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 allowing a medical device

Medical device

A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

 to be marketed without requiring evidence of effectiveness

Effectiveness

Effectiveness is the capability of producing a desired result. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression.-Etymology:...

. 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

Rare disease

A rare disease, also referred to as an orphan disease, is any disease that affects a small percentage of the population.Most rare diseases are genetic, and thus are present throughout the person's entire life, even if symptoms do not immediately appear...

or condition (i.e. less than 4,000 people in the US annually). 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.