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Humanitarian Device Exemption (HDE) Program Guidance for Industry and Food and Drug Administration Staff June 2018


Not for implementation. Contains non-binding recommendations.

Humanitarian Device Exemption (HDE) Program

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA developed this draft guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program. This programmatic draft guidance addresses commonly asked questions about HDEs and Humanitarian Use Devices (HUDs), including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the HDE Program. This draft guidance document reflects changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures Act (Cures Act) and explains the criteria FDA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 HUD. This draft guidance document also reflects amendments made to the HDE provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA). Once finalized, this guidance will supersede “Guidance for HDE holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff, Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers,” issued July 8, 2010.

For the purposes of this guidance, “you” refers to the HDE applicant or holder, and “we” refers to FDA. FDA’s guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is 101 suggested or recommended, but not required.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.