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  Ideas and suggestions generated during this workshop may facilitate development of draft guidance to provide our initial thoughts regarding the content of premarket submissions for emerging BCI technologies and help to speed development and approval of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

Preliminary Agenda

Time Event Speaker
9:00–9:10 Opening Remarks Carlos Pena / Victor Krauthamer
9:10–9:25 White House Neuroscience Initiative Phillip Rubin
9:25–9:45 FDA Regulatory process Michael Hoffmann
9:45–10:00 FDA Regulatory Science Eugene Civillico / Cristin Welle
10:00–10:10 Improving patient access to BCI devices and through early collaboration with FDA and payers Murray Sheldon
10:10–10:20 DARPA-FDA collaborations and DARPA BCI efforts Douglas Weber
10:25–10:35 Q&A  
10:35–10:50 State-of-the-Art BCI device technology Jose Contreras-Vidal
10:50–11:05 Patient perspectives Jennifer French
11:05–11:20 Clinical endpoints TBD
11:20–11:35 Translational challenges Hunter Peckham / Megan Moynahan
11:35–11:50 Perspectives from marketed neural prosthetic technology Timothy Denison
11:50–12:00 Q&A  
12:00–12:30 Lunch  
12:30–4:05 Breakout sessions:
  • Clinical
  • Endpoints
  • Non-clinical Device Testing
  • Research & Development and Translational issues
 
4:05–4:25 Break  
4:25–5:25 Breakout Session Summaries  
5:25–5:30 Closing Remarks  

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by close of business on November 12, 2014.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

Attendance In-Person
Webcast
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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: 10/17/2014
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