FDA Issues Final Guidance on Humanitarian Device Exemption Program

Today, the U.S. Food and Drug Administration (FDA) issued a final guidance, Humanitarian Device Exemption (HDE) Program .  This final guidance provides updated information on the operational aspects of the HDE Program and describes how the FDA determines whether to approve a humanitarian device exemption application for a device that is meant to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States. The FDA is also issuing an update to the Humanitarian Use Device (HUD) Designations guidance to align it with the annual patient population threshold for a HUD designation laid out in the 21st Century Cures Act. Manufacturers need to receive a HUD designation before submitting an HDE application.  About this Final Guidance:    It supersedes the "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. It includes a filing checklist for HDE applicants to clarify the information needed to consider the HDE sufficiently complete to permit substantive review.  It reflects updates to the allowable size of the patient population and changes in review committee requirements.

Read the Final Guidance

Upcoming Webinar for Industry On October 21, 2019, the FDA will host a webinar for manufacturers and others interested in learning more about this final guidance Questions?  If you have questions about this final guidance, contact the Division of Industry and Consumer Education (DICE).