FDA Workshop

March 22, 2011

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The AAN has been invited to be a co-sponsor at an FDA workshop along with the American Epilepsy Society and the National Academy of Neuropsychology. The workshop will investigate non-invasive devices for seizure detection, cognitive evaluation and traumatic brain injury/sports concussion assessment. The goal is to find out how clinical studies should be conducted and how the results should be conveyed to users so that the devices may be used safely and effectively.

Assuring the Safety and Effectiveness of Seizure, Cognitive Function, and TBI/Sports Concussion Diagnostic Devices

  • Algorithm verification/validation approaches
  • Information for device users
  • Regulatory requirements
Dates:June 2 - 3, 2011
Location:Food and Drug Administration
White Oak Campus
10903 New Hampshire Ave
Building 31
Silver Spring, MD 20993