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# Draft Guide on Humanitarian Device Exemption Program
- URL: https://www.fdaweb.com/draft-guide-on-humanitarian-device-exemption-program-2/
- Published: 2018-06-14T12:00:00.000Z
- Updated: 2026-09-15T00:13:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141688

*Federal Register* notice: FDA has made available a draft guidance entitled “Humanitarian Device Exemption (HDE) Program.”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 its decision-making process regarding marketing authorization for such devices. It also incorporates recent amendments that affect the HDE program and answers other common questions that FDA has received about the program. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-13/pdf/2018-12633.pdf?ref=fdaweb.com).