Medical Devices

Public Workshop - Brain-Computer Interface Devices for Patients with Paralysis and Amputation, November 21, 2014

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  Ideas and suggestions generated during this workshop may facilitate development of draft guidance to provide our initial thoughts regarding the content of premarket submissions for emerging BCI technologies and help to speed development and approval of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

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.

Discussion Paper

Webcast

Agenda and Presentations

TimeEventSpeaker
8:00Registration Opens IntroductionsJoyce Raines, Peggy Roney (FDA/CDRH)
Hilda F. Scharen (FDA/CDRH)
IntroductionsHilda F. Scharen (FDA/CDRH)
9:00 – 9:10Opening Remarks (PDF - 719KB)Carlos Pena / Victor Krauthamer (FDA, CDRH)
9:10 – 9:25White House Neuroscience InitiativePhillip Rubin (White House OSTP)
9:25 – 9:45FDA Regulatory Process (PDF - 149KB)Michael Hoffmann (FDA, CDRH)
9:45 – 10:00Regulatory Science Support of Device Innovation (PDF - 1.56MB)Eugene Civillico / Cristin Welle (FDA, CDRH)
10:00 – 10:10Improving Patient Access Though Early Collaboration (PDF - 268KB)Ken Skodacek (FDA, CDRH)
10:10 – 10:20DARPA-FDA Collaborations and DARPA BCI efforts (PDF - 905KB)Douglas Weber (DARPA Biotechnology Office)
10:25 – 10:35Q&A 
10:35 – 10:50State-of-the-Art BCI Device Technology (PDF - 833KB)Jose Contreras-Vidal (University of Houston)
10:50 – 11:05Patient Perspectives (PDF - 1.2MB)Jennifer French (Neurotech Network)

11:05 – 11:20
Clinical Endpoints (PDF - 3.23MB)Tiffany Ryan (Advanced Arm Dynamics)
11:20 – 11:35Translational challenges for BCI: Learning from History (PDF - 673KB)Hunter Peckham (Case Western Reserve University) / Megan Moynahan (Institute for Functional Restoration)
11:35 – 11:50Challenges and Opportunities of Brain-Machine-Interfacing… One Industry Perspective (PDF - 2.19MB)Timothy Denison (Medtronic)
11:50 – 12:00Q&A 
12:00 – 12:30Lunch 
12:30 – 4:05Breakout sessions:
  • Clinical Endpoints
  Jennifer Collinger (University of Pittsburgh)
Leigh Hochberg (Massachusetts General Hospital)
Naomi Kleitman (Craig H. Neilsen Foundation)
 
  • Non-clinical Device Testing
John Donoghue (Brown University)              
Joseph Pancrazio (George Mason University)
Dustin Tyler (Case Western Reserve University)
 
  • Research & Development and Translational issues
Jack Judy (University of Florida)
Kip Ludwig (NIH, NINDS)
Hunter Peckham (Case Western Reserve University)
Megan Moynahan (Institute for Functional Restoration)
4:05 – 4:25Break 
4:25 – 5:25Breakout Session Summaries 
5:25 – 5:30Closing Remarks 

Registration to Attend the Workshop

As of November 13th, online registration has closed. On-site registration will be available.

Contact Us

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, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contactHilda 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, hilda.scharen@fda.hhs.gov.

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.

Page Last Updated: 12/01/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.