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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 4,000 people in the US annually).〔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〕 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.〔http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm〕
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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