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. 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 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]
gollark: Perhaps it just has really inaccurate IP address geolocation data.
gollark: It is guessing based on IP address, probably.
gollark: Presumably. It does mean fewer projects and stuff going on though.
gollark: The server seems quite quiet right now. I don't know about *oddly* quiet compared to previous Sundays, but definitely quite quiet.
gollark: I generally just host stuff like this off my home server, which is very slow but works better than random free services.
See also
- Federal Food, Drug, and Cosmetic Act
- Premarket approval
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. "Humanitarian Device Exemption". www.fda.gov.
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