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.
You can access and download the final workshop agenda, as well as each of the presentations at the American Academy of Neurology's website.
Introduction to Neurodiagnostic and Psychometric Devices
Sara Doll Aguel
Biomedical Engineer/Lead Scientific Reviewer
Neurodiagnostic and Neurotherapeutic Devices Branch
Division of Ophthalmic, Neurological and ENT Devices
Food and Drug Administration
Brian Litt, MD
Associate Professor of Neurology
Department of Bioengineering
University of Pennsylvania
Natalie Getzoff, MD
Medical Officer, Neurodiagnostic and Neurotherapeutic Devices Branch
Divison of Ophthalmic, Neurological, and ENT Devices
Food and Drug Administration
Computerized Cognitive Assessment
Gordon Chelune, Ph.D., ABPP(CN)
Professor, Department of Neurology
Center for Alzheimer's Care, Imaging and Research
University of Utah
Alison Cernich, Ph.D., ABPP
Acting VA Senior Liaison, TBI
Defense Centers of Excellence for Psychological Health and TBI
Ruben Echemendia, Ph.D.
National Academy of Neuropsychology
Barry Jordan, MD
Associate Professor Clinical Neurology
Weill Medical College of Cornell University
Director, Brain Injury Program
Burke Rehabilitation Hospital
NFL PLayers Association Mackey-White TBI Committee
Information for Device Manufacturers
General Information of Types and Contents of Submissions to FDA
The FDA Division of Small Manufacturers, International and Consumer Assistance (DSMICA) provides assistance with the 510(k) process. This weblink to DSMICA http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ucm142656.htm, provides contact information and access to the webpages under the heading “How to Market Your Device” which discuss the types and contents of the submissions to the FDA.
Specific questions on the clinical trials of neurological devices
Please submit a pre-submission (Pre-IDE) to FDA to the address below. This gives FDA a chance to review your proposal and discuss it internally before responding.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
IDE Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
In general, your preIDE submission should include the following:
1. Specific questions you would like FDA’s feedback.
2. A detailed device description which should include the following:
3· Your proposed Indications for Use and all your desired claims
4. Summary of previous and relevant data/studies (and how they relate/are applicable to your current device)
FDA usually provides feedback, in writing, on a pre-IDE around the 60th day after receipt. If you would like to hold a face-to-face meeting or teleconference, please indicate so on your cover letter. This meeting is scheduled after staff hav provided comments to the pre-IDE and received follow-up quesions associated with the comments.
For additional guidance on pre-IDE, please refer to: