Saturday, December 12, 2015

FDA Public Meeting on Computerized Cognitive Assessment

Public Workshop - Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop, November 19-20, 2015

Meeting homepage with links to agenda, background papers, and webcast streams from the meeting.


"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."



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