Medical Devices

FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway – Wednesday, March 22, 2017

The FDA is hosting a webinar on Wednesday, March 22 from 1:00 – 2:30 p.m. ET for developers and sponsors of neurological devices on the De Novo pathway, an alternate pathway to classify novel devices automatically placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission.

This webinar will provide:

  • An introduction to the FDA’s role in facilitating innovation in neurological device technology
  • An overview of the De Novo classification process
  • Information on working with the FDA and the pre-submission process

Webinar Details:

Registration is not necessary
Date: March 22, 2017
Time: 1:00 – 2:30 p.m. Eastern Time
Target Audience: Neurological device developers, sponsors and innovators
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

To hear the presentation and ask questions dial:
In the US: 888-955-8972
International: 1-517-308-9086
Passcode: 1891131

To view the slide presentation during the webinar:

Conference number: PW3106674
Audience passcode: 1891131

Following the webinar, a transcript, recording and slides will be available at: on Thursday March 30. The slide presentation will also be available at this site on the morning of the webinar.

As always, we appreciate your feedback. Following the conclusion of the webinar, please complete a short survey about your FDA CDRH webinar experience. The survey can be found at immediately following the conclusion of the live webinar.

NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.

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

Page Last Updated: 05/18/2017
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