- October 21, 2019
- Organized By:
Summary: On Monday, October 21, 2019, 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.
Background: 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.