Webcast
Event Title
Webinar - Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway
August 27, 2020
Event Title
Webinar - Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway
August 27, 2020
- Date:
- August 27, 2020
- Time:
-
1:00 PM - 2:30 PM ET
Webinar Materials:
Summary:
On Thursday, August 27, 2020, the U.S. Food and Drug Administration (FDA) hosted a webinar for developers and manufacturers of neurological and physical medicine devices on the De Novo pathway, a potential pathway to market new medical devices for which there is no legally marketed predicate device.
This webinar provided:
- An introduction to the FDA’s role in facilitating innovation in neurological and physical medicine device technology.
- An overview of the De Novo classification process.
- Information on working with the FDA and the pre-submission process.
Background:
As part of the FDA's ongoing effort to ensure patients and providers have timely and continued access to safe, effective, and high-quality medical devices, today's webinar will provide developers and sponsors of neurological and physical medicine devices with information on the De Novo pathway.