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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:
8:00 PM - 8:00 PM ET

          

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