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 hosted 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 provided:

  • 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

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: 09/12/2018
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