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# Draft Guide on Humanitarian Device Exemption Program
- URL: https://www.fdaweb.com/draft-guide-on-humanitarian-device-exemption-program/
- Published: 2018-06-12T12:00:00.000Z
- Updated: 2026-09-15T00:12:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141658

FDA has issued a [draft guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM389275.pdf?ref=fdaweb.com) on its “Humanitarian Device Exemption (HDE) Program” that clarifies the current review practices for the regulatory pathway. The document addresses commonly asked questions about HDEs, including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the program. Additionally, the draft reflects changes in the HDE Program resulting from statutory amendments and explains the criteria FDA considers to determine if “probable benefit” has been demonstrated as part of the decision-making process regarding marketing authorization.