Document ID: FDA-2021-N-0008-0003
Agency: fda
Document Type: Notice
Title: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2021-05-14T04:00Z

[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26524-26525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10167]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0008]

Neurological Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Neurological Devices Panel of 
the Medical Devices Advisory Committee. The general function of the 
committee is to provide advice and recommendations to the Agency on 
FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will take place virtually on June 3 and 4, 2021, 
from 9 a.m. Eastern Time to 6 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19 
pandemic, all meeting participants will be joining this advisory 
committee meeting via an online teleconferencing platform. Answers to 
commonly asked questions about FDA advisory committee meetings may be 
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: James Swink, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 
james.swink@fda.hhs.gov, 301-796-6313, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's website https://www.fda.gov/advisory-committees/medical-devices/medical-devices-advisory-committee 
and scroll down to the appropriate advisory committee meeting link or 
call the advisory committee information line to learn about possible 
modifications before the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On June 3, 
2021, during session I, the committee will discuss and make 
recommendations regarding the classification of topical refrigerants 
(vapocoolants), which are currently unclassified preamendment devices, 
to class II (general and special controls). During session II, the 
committee will discuss and make recommendations regarding the 
classification of acupressure devices, which are currently unclassified 
preamendment devices, to class I (general controls). During session 
III, the committee will discuss and make recommendations regarding the 
classification of electro-acupuncture stimulators, which are currently 
unclassified preamendment devices, to class II (general and special 
controls).
    On June 4, 2021, during session I, the committee will discuss and 
make recommendations regarding the classification of attention task 
performance recorders, which are currently unclassified preamendment 
devices, to class II (general and special controls). During session II, 
the committee will discuss and make recommendations regarding the 
classification of optical contour sensing devices, which are currently 
unclassified preamendment devices, to class I (general controls). 
During session III, the committee will discuss and make recommendations 
regarding the classification of plunger-like joint manipulators, which 
are currently unclassified preamendment devices, to class II (general 
and special controls).
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting, and the background material 
will be posted on FDA's website after the meeting. Background material 
and the link to the online teleconference meeting room will be 
available at https://www.fda.gov/advisory-committees/medical-devices/medical-devices-advisory-committee. Scroll down to the appropriate 
advisory committee meeting link. The meeting will include slide 
presentations with audio components to allow the presentation of 
materials in a manner that most closely resembles an in-person advisory 
committee meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
21, 2021. Oral presentations from the public will be scheduled on June 
3 and June 4, 2021, between approximately 9:15 a.m. and 10:15 a.m. 
Eastern Time. Those individuals interested in making formal oral 
presentations should notify the contact person (see FOR FURTHER 
INFORMATION CONTACT). The notification should include a brief statement 
of the general nature of the evidence or arguments they wish to 
present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before May 13, 2021. Time allotted for each presentation may be 
limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will

[[Page 26525]]

notify interested persons regarding their request to speak by May 14, 
2021.
    For press inquiries, please contact the Office of Media Affairs at 
fdaoma@fda.hhs.gov or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Ann Marie Williams at Annmarie.Williams@fda.hhs.gov or 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10167 Filed 5-13-21; 8:45 am]
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