NOT-NS-16-006: Notice of NIH/FDA Informational Webinar - Common Misunderstandings of the Investigational Device Exemption Process for Invasive Neuromodulation Devices

Notice of NIH/FDA Informational Webinar - Common Misunderstandings of the Investigational Device Exemption Process for Invasive Neuromodulation Devices

Notice Number: NOT-NS-16-006

Key Dates
Release Date: January 29, 2016

Related Announcements
RFA-NS-16-009
RFA-NS-16-010
RFA-NS-16-011
RFA-NS-16-018

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

This Notice is to inform potential applicants to Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative FOAs for Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (RFA-NS-16-009, RFA-NS-16-010, RFA-NS-16-011 and RFA-NS-16-018) of a webinar with both FDA and NIH staff to provide assistance for the Investigational Device Exemption (IDE) process for neuromodulation devices. The webinar is optional and is not required for submission to RFA-NS-16-009, RFA-NS-16-010, RFA-NS-16-011 or RFA-NS-16-018. To register for the webinar, and to submit questions, please email [email protected] by Tuesday, February 23, 2016.

Webinar Information
Date: Thursday, February 25, 2016
Time: 3:00PM EDT
Duration: 1 hour

Inquiries

Please direct all inquiries to:

Stephanie Fertig, MBA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: [email protected]