Notice2021-12266
Gastroenterology and Urology 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
June 11, 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 Gastroenterology and Urology 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 111 (Friday, June 11, 2021)</title>
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[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Page 31315]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12266]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Gastroenterology and Urology 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 Gastroenterology and Urology
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 July 14, 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/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. 5211, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#dc96bdb1b9aff28fabb5b2b79cbab8bdf2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="cd87aca0a8bee39ebaa4a3a68daba9ace3a5a5bee3aaa2bb">[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 July 14,
2021, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application (PMA) for the
Organ Care System (OCS) Liver System, by TransMedics, Inc. The proposed
Indication for Use for the OCS Liver System, as stated in the PMA, is
as follows:
The TransMedics[supreg] Organ Care System (OCS<SUP>TM</SUP>) Liver
is a portable extracorporeal liver perfusion and monitoring system
indicated for the resuscitation, preservation, and assessment of liver
allografts from donors after brain death (DBD) or liver allografts from
donors after circulatory death (DCD) <=55 years old in a near-
physiologic, normothermic and functioning state intended for a
potential transplant recipient.
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/advisory-committees/medical-devices-advisory-committee/gastroenterology-urology-devices-panel">https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/gastroenterology-urology-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 July
7, 2021. Oral presentations from the public will be scheduled on July
14, 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 June
29, 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 June 30, 2021.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#0b6d6f6a64666a4b6d6f6a25636378256c647d"><span class="__cf_email__" data-cfemail="c0a6a4a1afada180a6a4a1eea8a8b3eea7afb6">[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 Mallet at <a href="/cdn-cgi/l/email-protection#b8f9caccd9d1ca96f5d9d4d4ddccccf8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="e2a39096838b90ccaf838e8e879696a2848683cc8a8a91cc858d94">[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: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12266 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P
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