Presentations and Webcast Replay added to Public Workshop – Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop, November 19

The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, “Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop.” The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus of the second day of the workshop will be non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function.

• Discussion Paper: “Neurodiagnostic Devices Intended to Assess Cognitive Function”
• Discussion Paper: “External Electromagnetic Neurostimulation Devices Intended to Improve Normal Cognitive Function in Healthy Individuals”
• Date, Time and Location
• Federal Register Notice
• Agenda
• Webcast
• Contact Us

FDA Campus Information (Airports, Directions, Lodging Accommodations, Public Transportation, etc.)

The meeting will be webcast.

Draft Agenda

Day One: November 19, 2015

Day Two: November 20, 2015

Webcast

Archived Webcast Links:

• Webcast Part 1
• Webcast Part 2
• Webcast Part 3  

 

For questions regarding workshop content please contact:

Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, Bldg 66, rm 3625, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6815, [email protected]

Jay Gupta, Neurostimulation Devices Branch, Division of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-2795, [email protected]