- September 13, 2016
08:00 PM - 08:00 PM EDT
As part of the FDA’s ongoing effort to assure patients and providers have timely and continued access to safe, effective, and high quality medical devices, the FDA hosted a webinar for investigators and sponsors on how to move a product to the U.S. marketplace.
This webinar was part of the FDA’s partnership in the White House BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative® focused on understanding the human brain and uncovering new ways to treat, prevent and cure brain disorders.
This webinar focused on:
- Neurological devices, initiating a medical device study, and Investigational Device Exemptions (IDEs)
- First in Human studies, Early Feasibility studies, and traditional feasibility studies
- FDA engagement and the pre-submission process