Humanitarian Use Device
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A Humanitarian Device Exemption is an approval process provided by the United States
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
allowing a
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
to be marketed without requiring evidence of
effectiveness Effectiveness or effectivity is the capability of producing a desired result or the ability to produce desired output. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression. Et ...
. 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 A rare disease is any disease that affects a small percentage of the population. In some parts of the world, the term orphan disease describes a rare disease whose rarity results in little or no funding or research for treatments, without financi ...
or condition (i.e. fewer than 8,000 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.


See also

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Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the food safety ...
*
Premarket approval The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of ...


Notes

Food and Drug Administration {{medical-equipment-stub