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.
- Date, Time and Location
- Federal Register Notice
- Registration
- Contact Us
Date, Time and Location
This 2-day workshop will be held November 19-20, 2015, beginning at 8:30 a.m. – 5:00 p.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
- FDA Campus Information (Airports, Directions, Lodging Accommodations, Public Transportation, etc.)
The meeting will be webcast.
Registration to Attend the Workshop
If you wish to attend this Workshop, you must register by close of business on November 6, 2015.
There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, [email protected].
If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at [email protected] at least 7 days in advance of the meeting.
Contact Us
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]
