Webinar: FDA Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions
The Food and Drug Administration (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
More information is available via the FDA's website.