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
Notes
- ↑ Field, M. Tilson, H. (2006). Safe medical devices for children, National Academies Press
- ↑ Chin, R. Lee B. (2008). Principles and Practice of Clinical Trial Medicine, Elsevier
- ↑ Health, Center for Devices and Radiological (3 October 2022). "Humanitarian Device Exemption". www.fda.gov. Archived from the original on June 3, 2009.
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