Document ID: FDA-2021-N-0008-0004
Agency: fda
Document Type: Notice
Title: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2021-06-11T04:00Z

[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Page 31315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.

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, 
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 at https://www.fda.gov/AdvisoryCommittees/default.htm 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 (OCSTM) 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 
https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/gastroenterology-urology-devices-panel. 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 
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 Artair Mallet at Artair.Mallett@fda.hhs.gov 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 https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings 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