Notice2021-18394
General and Plastic Surgery 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
August 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 General and Plastic Surgery 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 163 (Thursday, August 26, 2021)</title>
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[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47645-47646]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18394]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
General and Plastic Surgery 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 General and Plastic Surgery
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.
[[Page 47646]]
DATES: The meeting will take place virtually on October 20, 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 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: Candace Nalls, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#2447454a404547410a4a45484857644240450a4c4c570a434b52"><span class="__cf_email__" data-cfemail="c5a6a4aba1a4a6a0ebaba4a9a9b685a3a1a4ebadadb6eba2aab3">[email protected]</span></a>, 301-636-0510, 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 October
20, 2021, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application (PMA) for the
SurgiMend PRS Acellular Bovine Dermal Matrix (SurgiMend PRS ABDM) by
Integra LifeSciences Corporation. The proposed Indication for Use, as
stated in the PMA, is as follows: SurgiMend PRS Acellular Bovine Dermal
Matrix is intended for use as soft tissue support in post-mastectomy
breast reconstruction. SurgiMend PRS Acellular Bovine Dermal Matrix is
specifically indicated for immediate, two-stage, submuscular,
alloplastic breast reconstruction.
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/general-and-plastic-surgery-devices-panel">https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/general-and-plastic-surgery-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
October 6, 2021. Oral presentations from the public will be scheduled
on October 20, 2021, between approximately 2 p.m. Eastern Time and 3
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 September 28, 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 sessions. The contact
person will notify interested persons regarding their request to speak
by September 29, 2021.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#5a3c3e3b35373b1a3c3e3b74323229743d352c"><span class="__cf_email__" data-cfemail="a2c4c6c3cdcfc3e2c4c6c38ccacad18cc5cdd4">[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 Ann Marie Williams at <a href="/cdn-cgi/l/email-protection#95f4fbfbf8f4e7fcf0bbe2fcf9f9fcf4f8e6d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="83e2ededeee2f1eae6adf4eaefefeae2eef0c3e5e7e2adebebf0ade4ecf5">[email protected]</span></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: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18394 Filed 8-25-21; 8:45 am]
BILLING CODE 4164-01-P
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