On Thursday, August 27, 2020, the U.S. Food and Drug Administration (FDA) will host 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 will provide:
* 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.
* We encourage all interested stakeholders to join. Registration is not necessary.