The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Brain-Computer Interface (BCI) Devices for Patients with Paralysis and Amputation”.
The purpose of this workshop is to obtain feedback on scientific, clinical, and regulatory considerations associated with BCI devices. Ideas and suggestions generated during this workshop may facilitate development of draft guidance to provide our initial thoughts regarding the content of premarket submissions for emerging BCI technologies and help to speed development and approval of future submissions.
- Date, Time and Location
- Federal Register Notice
- Discussion Paper
- Agenda and Presentations
- Contact Us
This meeting will be held November 21, 2014, beginning at 8:30 a.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
The workshop general session will also be available via webcast.
Agenda and Presentations
|8:00||Registration Opens Introductions||Joyce Raines, Peggy Roney (FDA/CDRH)|
Hilda F. Scharen (FDA/CDRH)
|Introductions||Hilda F. Scharen (FDA/CDRH)|
|9:00 – 9:10||Opening Remarks (PDF - 719KB)||Carlos Pena / Victor Krauthamer (FDA, CDRH)|
|9:10 – 9:25||White House Neuroscience Initiative||Phillip Rubin (White House OSTP)|
|9:25 – 9:45||FDA Regulatory Process (PDF - 149KB)||Michael Hoffmann (FDA, CDRH)|
|9:45 – 10:00||Regulatory Science Support of Device Innovation (PDF - 1.56MB)||Eugene Civillico / Cristin Welle (FDA, CDRH)|
|10:00 – 10:10||Improving Patient Access Though Early Collaboration (PDF - 268KB)||Ken Skodacek (FDA, CDRH)|
|10:10 – 10:20||DARPA-FDA Collaborations and DARPA BCI efforts (PDF - 905KB)||Douglas Weber (DARPA Biotechnology Office)|
|10:25 – 10:35||Q&A|
|10:35 – 10:50||State-of-the-Art BCI Device Technology (PDF - 833KB)||Jose Contreras-Vidal (University of Houston)|
|10:50 – 11:05||Patient Perspectives (PDF - 1.2MB)||Jennifer French (Neurotech Network)|
11:05 – 11:20
|Clinical Endpoints||Tiffany Ryan (Advanced Arm Dynamics)|
|11:20 – 11:35||Translational challenges for BCI: Learning from History (PDF - 673KB)||Hunter Peckham (Case Western Reserve University) / Megan Moynahan (Institute for Functional Restoration)|
|11:35 – 11:50||Challenges and Opportunities of Brain-Machine-Interfacing… One Industry Perspective (PDF - 2.19MB)||Timothy Denison (Medtronic)|
|11:50 – 12:00||Q&A|
|12:00 – 12:30||Lunch|
|12:30 – 4:05||Breakout sessions: || Jennifer Collinger (University of Pittsburgh)|
Leigh Hochberg (Massachusetts General Hospital)
Naomi Kleitman (Craig H. Neilsen Foundation)
|John Donoghue (Brown University) |
Joseph Pancrazio (George Mason University)
Dustin Tyler (Case Western Reserve University)
|Jack Judy (University of Florida)|
Kip Ludwig (NIH, NINDS)
Hunter Peckham (Case Western Reserve University)
Megan Moynahan (Institute for Functional Restoration)
|4:05 – 4:25||Break|
|4:25 – 5:25||Breakout Session Summaries|
|5:25 – 5:30||Closing Remarks|
As of November 13th, online registration has closed. On-site registration will be available.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact: Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, firstname.lastname@example.org.
For questions regarding workshop content please contact: Hilda Scharen Center Science Council, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-6815, email@example.com.
In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is December 22, 2014.
Regardless of attendance at the public workshop, interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section II, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.