Humanitarian Device Exemption
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A Humanitarian Device Exemption can be provided by the United States FDA and allows a medical device to be marketed without requiring evidence of effectiveness. To qualify the device must be intended to benefit patients with a rare disease or condition (i.e. less than 4,000 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]
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- Jump up ↑ Field, M. Tilson, H. (2006). Safe medical devices for children, National Academies Press
- Jump up ↑ Chin, R. Lee B. (2008). Principles and Practice of Clinical Trial Medicine, Elsevier
- Jump up ↑ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm
