Notice2021-14212
Circulatory System 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
July 2, 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 Circulatory System 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 125 (Friday, July 2, 2021)</title>
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[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35303-35304]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14212]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Circulatory System 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 Circulatory System 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 August 3, 2021, from 9
a.m. Eastern Time to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of the 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Avenue, Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
[[Page 35304]]
aden.asefa@<a href="http://fda.hhs.gov">fda.hhs.gov</a>, 301-796-0400, 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 August 3,
2021, the committee will discuss and make recommendations on
information regarding the premarket notification (510(k)) submission
for the TriGUARD 3 Cerebral Embolic Protection Device. The proposed
indication for use for the TriGUARD 3 Cerebral Embolic Protection
Device, is as follows:
The TriGUARD 3 Cerebral Embolic Protection Device is designed to
minimize the risk of cerebral damage by deflecting embolic debris away
from the cerebral circulation during trans-catheter aortic valve
replacement.
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. Background material and the
link to the online teleconference meeting room will be available at
<a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. 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 July
27, 2021. Oral presentations from the public will be scheduled between
approximately 1 p.m. Eastern Time 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 July 21, 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 July 20, 2021.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#610705000e0c00215d0041091304075c" http: fda.hhs.gov">fda.hhs.gov</a>">fdaoma@<a href="http://fda.hhs.gov">fda.hhs.gov</a></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 AnnMarie Williams at <a href="/cdn-cgi/l/email-protection#7a3b1414371b08131f542d131616131b17093a461b5a12081f1c47" http: fda.hhs.gov">fda.hhs.gov</a>">AnnMarie.Williams@<a href="http://fda.hhs.gov">fda.hhs.gov</a></a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</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: June 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14212 Filed 7-1-21; 8:45 am]
BILLING CODE 4164-01-P
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