[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48869-48870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2711]


Neurodiagnostics and Non-Invasive Brain Stimulation Medical 
Devices; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following two-day public workshop entitled, ``Neurodiagnostics and Non-
Invasive Brain Stimulation Medical Devices Workshop''. The focus of the 
first day of the workshop will be cognitive assessment medical devices, 
which are intended to provide healthcare professionals with an 
evaluation of cognitive function through non-invasive measurements. The 
focus of the second day of the workshop will be non-invasive brain 
stimulation medical devices, which are medical devices that are 
intended to improve, affect, or otherwise modify the cognitive function 
of a normal individual (i.e., without a treatment objective) by means 
of non-invasive electrical or electromagnetic stimulation to the head. 
The purpose of this workshop is to obtain public input and feedback on 
scientific, clinical, and regulatory considerations associated with 
medical devices for assessing and influencing cognitive function. Ideas 
generated during this workshop may facilitate further development of 
guidance regarding the content of premarket submissions for 
neurodiagnostics and non-invasive brain stimulation medical devices and 
help to speed development and approval of future submissions.
    Dates and Times: The public workshop will be held on November 19 
and 20, 2015, from 8:30 a.m. to 5 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.

[[Page 48870]]

    Contact Persons: Hilda Scharen, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm 3625, Silver Spring, MD 20993, 301-796-6815, 
[email protected]; or Jay Gupta, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, [email protected], 301-796-2795.
    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 6, 2015, at 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, [email protected] or 301-796-5661 no 
later than November 5, 2015.
    To register for the public workshop, please visit FDA's Medical 
Devices Workshops and 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. Those without Internet access 
should contact Susan Monahan to register (see Contact for special 
accommodations). Registrants will receive confirmation after they have 
been accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be available via Webcast. Persons interested in viewing the 
Webcast must register online by 4 p.m., November 6, 2015. 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 10, 2015. If you have 
never attended a Connect Pro event before, test your connection at 
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. 
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: 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 5, 
2015.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document 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. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when providing comments to 
the topics as outlined in section II of this document, 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. The address of 
the Division of Freedom of Information is available on the Agency's Web 
site at http://www.fda.gov. 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).

SUPPLEMENTARY INFORMATION:

I. Background

    Cognitive assessment medical devices are intended to provide 
healthcare professionals with an evaluation of cognitive function 
through non-invasive measurements. Non-invasive brain stimulation 
medical devices are intended to improve, affect, or otherwise modify 
the cognitive function of a normal individual (i.e., has no cognitive 
impairment) by means of non-invasive electrical or electromagnetic 
stimulation to the head. These medical devices both present important 
safety and effectiveness questions as well as study design and data 
analysis challenges.

II. Topics for Discussion at the Public Workshop

    The workshop seeks to involve industry and academia in addressing 
scientific, clinical, and regulatory considerations associated with 
medical devices for assessing and influencing cognitive function. 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.
    This workshop is aimed to address scientific, clinical, and 
regulatory considerations associated with medical devices for assessing 
and influencing cognitive function; including, but not limited to, the 
following topic areas:
     Considerations for clinical study trial designs, patient 
populations, and patient selection methods;
     considerations for clinical study endpoints, e.g., 
clinically relevant outcome measures and related statistical analyses;
     identification of risks and risk mitigation strategies; 
and
     evaluation of prior studies, current clinical research, 
and available scientific and clinical evidence.

    Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19990 Filed 8-13-15; 8:45 am]
 BILLING CODE 4164-01-P