Webinar - Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies – Wednesday, September 14, 2016

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 is hosting a webinar on Wednesday, September 14 from 10:00 – 11:30am ET for investigators and sponsors of neurological devices on how to move a product to the U.S. marketplace.

This webinar will focus 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

This webinar is part of the FDA’s partnership in the White House BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, which is focused on understanding the human brain and uncovering new ways to treat, prevent and cure brain disorders.

More information about this webinar is available on www.fda.gov/CDRHWebinar.

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 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health