FDA Humanitarian Device Exemption (HDE) Overview
Humanitarian Device Exemption is a regulatory pathway including FDA 510k for medical devices intended to treat or diagnose diseases or conditions that affect fewer than 8,000 individuals per year in the United States. It allows market approval without evidence of effectiveness, but safety must be demonstrated.
Humanitarian Device Exemption Requirements
The marketing application submitted to FDA for a Humanitarian Device Exemption must be verified for the following. You may refer to the slide for more information.
- Device must not be available under another mechanism.
- Probable benefit outweighs the risk.
- No comparable device exists.
- Not for commercial profit
Content owner: Ms. Amrutha Rai, Team Lead, 510k Compliance