Webcast
Event Title
FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway – Wednesday, March 22, 2017
March 21, 2017
Event Title
FDA Webinar - Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway – Wednesday, March 22, 2017
March 21, 2017
- Date:
- March 21, 2017
- Time:
-
8:00 PM - 8:00 PM ET
Webinar Materials
- Presentation
- Printable Slides
- Transcript
- Case Study: Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device
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 [email protected]