Notice2021-23334
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 26, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 204 (Tuesday, October 26, 2021)</title>
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[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59167-59168]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23334]
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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 December 10, 2021, from
9 a.m. 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 including information regarding special
accommodations due to a disability may be accessed at: <a href="https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings">https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings</a>.
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,
[[Page 59168]]
MD 20993-0002, <a href="/cdn-cgi/l/email-protection#98d2f9f5fdebb6cbeff1f6f3d8fefcf9b6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="c78da6aaa2b4e994b0aea9ac87a1a3a6e9afafb4e9a0a8b1">[email protected]</span></a>, 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
at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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 December
10, 2021, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application (PMA) for the
BrainsGate Ischemic Stroke System (ISS500) by BrainsGate Ltd. The
proposed indications for use, submitted by the sponsor, as stated in
the PMA, are as follows: The ISS500 is indicated to increase cerebral
blood flow and reduce disability in adult patients with acute ischemic
stroke with confirmed cortical involvement in the anterior circulation
who are ineligible or have no access to IV-tPA and endovascular
thrombectomy. Treatment is to be initiated between 8 and 24 hours from
stroke onset (last known well).
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 <a href="https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/neurological-devices-panel">https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/neurological-devices-panel</a>. Select the link for the
2021 Meeting Materials. 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
November 29, 2021. Oral presentations from the public will be scheduled
on December 10, 2021, between approximately 1 p.m. and 2 p.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
November 18, 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 notify
interested persons regarding their request to speak by November 19,
2021.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#afc9cbcec0c2ceefc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="5b3d3f3a34363a1b3d3f3a75333328753c342d">[email protected]</span></a> 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 Artair Mallett at <a href="/cdn-cgi/l/email-protection#d091a2a4b1b9a2fe9db1bcbcb5a4a490b6b4b1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="105162647179623e5d717c7c756464507674713e7878633e777f66">[email protected]</span></a> or 301-796-9638 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 <a href="https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings">https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings</a> 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: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23334 Filed 10-25-21; 8:45 am]
BILLING CODE 4164-01-P
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