FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions (HDEs) - Monday, December 18, 2017

On Monday, December 18, from 12:00 – 1:30 p.m. ET, the FDA will host “An Introduction to Humanitarian Device Exemptions (HDEs)” webinar for developers and sponsors of neurological devices intended for diseases or conditions that affect small (rare) populations. During this webinar, the FDA will provide:  An overview of the HDE regulatory pathway Information about humanitarian use devices (HUDs), including information about use in pediatric populations   Helpful tips for completing an HDE application Discussion of HDE manufacturing concerns    Following the presentation, FDA subject matter experts will respond to questions from attendees. This webinar is part of the FDA’s commitment to increase transparency and clarify the regulatory process for neurological devices with the goal of assuring U.S. patients and health care professionals have timely and continued access to safe, effective, and high quality medical devices. This is the fourth webinar in a series for developers and sponsors of neurological devices. More information about this webinar is available on www.fda.gov/CDRHWebinar. As always, we appreciate your feedback. Following the conclusion of the webinar, please complete a short survey about your FDA medical device webinar experience. The survey can be found atwww.fda.gov/CDRHWebinar. If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 ordice@fda.hhs.gov. Food and Drug Administration Center for Devices and Radiological Health