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  5. Webinar - Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies - Wednesday, September 14, 2016
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Regulatory Advice for Investigators and Sponsors of Neurological Devices and the Path to Initiating Human Studies - Wednesday, September 14, 2016
September 13, 2016


Date:
September 13, 2016
Time:
08:00 PM - 08:00 PM EDT

          

Webinar Materials

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