Webinar Materials

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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