Reminder: Webinar - Humanitarian Device Exemption Program

On Monday, October 21, 2019, from 12:00-1:30 p.m., EDT, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions about the Humanitarian Device Exemption Program Final Guidance published on September 5, 2019. This final guidance describes how the FDA determines whether to approve a humanitarian device exemption application for a device that is meant to treat or diagnose populations with uncommon medical conditions. This final guidance supersedes “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. This guidance provides clarity to industry and FDA staff about current review practices for the Humanitarian Device Exemption (HDE) Program. This guidance explains updates to the size of the patient population and the changes in review committee requirements. No registration is required.

Join the Webinar on October 21 Questions? If you have any questions about this webinar, please contact the Division of Industry and Consumer Education.