martes, 14 de marzo de 2017

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

FDA Logo
The FDA is hosting a webinar on Wednesday, March 22, 2017 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
This webinar is part of the FDA’s commitment to increase transparency of the regulatory landscape for neurological devices with the goal of assuring U.S. patients and health care professionals have timely and continued access to safe, effective, and high quality medical devices. 
More information about this webinar is available on
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 will be available at immediately following the conclusion of the live webinar.
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 1-800-638-2041, 301-796-7100 or
Thank you,

Food and Drug Administration
Center for Devices and Radiological Health

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