Diagnostic Devices Workshop Brings Together Providers, Regulators, and Industry

On June 2-3, 2011, the FDA hosted a workshop co-sponsored by the American Academy of Neurology, the American Epilepsy Society, and the National Academy of Neuropsychology to discuss issues related to the validation and labeling of devices used to assess seizures, cognitive function, traumatic brain injury (TBI) and concussion. More than 200 people of various backgrounds attended the meeting, with clinicians, academicians/researchers, industry, and government (FDA, NIH and military) all represented.

On Day 1, six experts in all three fields presented a summary of the current clinical state of seizure detection, computerized cognitive assessment and TBI/concussion assessment. During a lunch session, two speakers addressed more specific TBI issues; and in the afternoon the attendees split into smaller breakout sessions. In these breakout sessions, attendees discussed questions the workshop planning committee (comprised of clinicians from the three professional societies, invited clinicians, and FDA) drafted prior to the meeting, while moderators (clinicians from the professional societies) directed the discussion. Questions were related to how validation studies for these devices should be designed and what type of information should be in the labeling to help users use the device safely and effectively. Discussions were productive and lively.

On Day 2 (a half day), the moderators from the three subgroups presented a summary of what was discussed in their breakout sessions and took questions from the audience. General consensus from all three groups included the following: event/disease to be detected should be clearly defined in the studies and labeling; clear definition of the users and environment of use are key to validation and labeling; performance results should be in labeling.

Overall feedback from attendees was that the workshop was a great first step toward establishing a dialogue between the different stakeholders and that there should be continued efforts toward providing guidelines for each area. Links to the meeting agenda, presentations, and breakout session summaries are provided below.