[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Pages 49091-49093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19576]



Food and Drug Administration

[Docket No. FDA-2014-N-1130]

Brain-Computer Interface Devices for Patients With Paralysis and 
Amputation; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Brain-

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Computer Interface (BCI) Devices for Patients With Paralysis and 
Amputation.'' BCI devices include neuroprostheses that interface with 
the central or peripheral nervous system to restore lost motor or 
sensory capabilities in paralyzed and amputee patients. The purpose of 
this workshop is to obtain public 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of draft guidance to provide our initial thoughts regarding the content 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 to help speed 
development and approval of future submissions.
    Dates and Times: The public workshop will be held on November 21, 
2014, from 8:30 a.m. to 5:30 p.m.
    Location: The public workshop will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Hilda Scharen, Center for Devices and Radiological 
Health, Food and Drug Administration, Bldg. 66, rm. 3625, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-6815, email: 
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by November 12, 2014, by 4 p.m. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the public workshop will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
susan.monahan@fda.hhs.gov no later than November 7, 2014.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this meeting/public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, email, and telephone number. If you 
are unable to register online, please contact Susan Monahan (see 
Registration.) Registrants will receive confirmation after they have 
been accepted and will be notified if they are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by Wednesday, November 12, 2014, by 4 p.m. Early 
registration is recommended because Webcast connections are limited. 
Organizations are requested to register all participants, but to view 
using one connection per location. Webcast participants will be sent 
technical system requirements after registration and will be sent 
connection access information after November 14, 2014. If you have 
never attended a Connect Pro event before, test your connection at 
To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site 
addresses in this document, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Comments: FDA is holding this public workshop to obtain information 
on the technical challenges of BCI devices. 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.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)


I. Background

    BCI devices have the potential to restore functional movement and 
sensory capabilities to individuals disabled by paralysis or 
amputation. BCI devices interface with the central and/or peripheral 
nervous system to detect neural control commands for real or virtual 
prosthetic or assistive devices. Investigational studies of BCI devices 
have revealed both device potential effectiveness and implementation 
challenges. Advancement of BCI devices from the laboratory to patients 
may be impeded by gaps in scientific and clinical data regarding long-
term device reliability and safety; uncertainty in the regulatory, 
reimbursement, and commercialization pathways; and the need for 
increased patient input in the device development process.
    The workshop seeks to involve industry and academia in addressing 
the challenges in the development of BCI devices. By bringing together 
relevant stakeholders, which include scientists, patient advocates, 
clinicians, researchers, industry representatives, and regulators, to 
this workshop, we hope to facilitate the improvement of this rapidly 
evolving product area.

II. Topics for Discussion at the Public Workshop

    This workshop is aimed to address the scientific, clinical, and 
regulatory considerations associated with these devices, including but 
not limited to, the following topic areas:
    1. Challenges, needs, and benefit/risk profiles for target patient 
    2. Device interoperability for complex, multi-component systems.

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    3. Technological metrics for invasive and non-invasive neural 
interfaces (i.e., reliability, biocompatibility, electromagnetic 
compatibility, software evaluation, and safety).
    4. For different stages of device development, considerations 
regarding appropriate selection of preclinical (bench and animal) 
testing methods, and patient-centered outcome metrics in clinical and 
``real world'' use settings.

    Dated: August 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19576 Filed 8-18-14; 8:45 am]