Humanitarian Device Exemption is an approval process for HUDs for marketing device without requiring evidence of effectiveness. The application for HDE is very similar to Premarket Approval (PMA) application. Since an HUD is exempted from the effectiveness requirements (unlike PMA application), an HDE application can be filled without the results of scientifically valid clinical investigations that demonstrate the device is effective and safe for proposed condition or disease. But it must contain the facts that the device has more health benefits than the associated risk of illness and injury compared to available devices or treatments. Upon approval of such applications, the applicant is authorized to market a Humanitarian Use Device subject to certain profit and usage restrictions.
