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

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


Date:
December 18, 2017
Time:
07:00 AM - 08:30 AM EST

  

Webinar Materials

On Monday, December 18, from 12:00 – 1:30 p.m. ET, the FDA hosted “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 provided:

  • 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

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 1-800-638-2014, 301-796-7100 or dice@fda.hhs.gov.