Humanitarian Device Exemption | FDA The Humanitarian Device Exemption Program provides a regulatory pathway for medical devices intended for diseases or conditions that affect small populations
Humanitarian Device Exemption - Wikipedia 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
FDA Fact Sheets: Humanitarian Device Exemption (HDE) Humanitarian Device Exemption (HDE) application is submitted to FDA to obtain approval for an HUD and takes part in a two-step process First, the company is required to file a humanitarian use device designation request
Humanitarian Device Exemption (HDE): 2025 FDA Guide Learn FDA's Humanitarian Device Exemption (HDE) pathway for rare disease devices affecting ≤8,000 patients Complete guide to HUD designation, profit restrictions IRB requirements
Humanitarian Device Exemption - i3cglobal. com Definition Origin: HDE is a regulatory pathway established by the FDA under 21 CFR 814 Subpart H and Section 520(m) of the FD C Act for devices treating ≤8,000 individuals annually
Humanitarian Device Exemption (HDE) Program | FDA FDA developed this guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program