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# Guide on Humanitarian Device Exemption Program
- URL: https://www.fdaweb.com/guide-on-humanitarian-device-exemption-program/
- Published: 2019-09-09T12:00:00.000Z
- Updated: 2026-09-15T01:48:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144951

*Federal Register* notice: FDA has made available a final guidance entitled “Humanitarian Device Exemption (HDE) Program.” The document explains the criteria FDA considers to determine if “probable benefit” has been demonstrated as part of the Agency’s decision-making process regarding marketing authorization for a humanitarian use device. The guidance also reflects recent amendments to the federal Food, Drug, and Cosmetic Act that affect the HDE program and answers common questions about the program. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-06/pdf/2019-19290.pdf?ref=fdaweb.com).