Zdrowie i gospodarka · 14/08/2015

Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments

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. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for neurodiagnostics and non-invasive brain stimulation medical devices and help to speed development and approval