Division of Clinical Research

Office of the Vice President and Innovation

  • Date: October 21, 2019
  • Time: 12:00 PM EDT-01:30 PM EDT
  • Registration is not necessary.

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

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.

Webinar Details:

  • Dial 800-369-3163
  • Conference Number: PWXW9442225
  • Passcode: 3000516

To view the slide presentation during the webinar: www.mymeetings.com/nc/join.php?i=PWXW9442225&p=3000516&t=cExternal Link Disclaimer

Following the webinar, a transcript, recording and slides will be available at: www.fda.gov/CDRHWebinar

Categories FDA Regulatory
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