Webinar: FDA Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions

December 18, 2017 12:00 pm - December 18, 2017 1:30 pm

Webinar: FDA Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to Humanitarian Device Exemptions

Government
Agency
Neuroscience

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.

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