[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51453-51454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18259]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, Health and Human Services (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 October 7, 2020, 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, visitor parking, and transportation may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
aden.asefa@fda.hhs.gov, 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 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 October 7, 2020, the committee will
discuss, make recommendations, and vote on information regarding the
premarket approval application (PMA) for the TransMedics Organ Care
System (OCS)--Heart, by TransMedics, Inc. The proposed Indication for
Use for the TransMedics OCS--Heart, as stated in the PMA, is as
follows:
The TransMedics OCS Heart System is a portable ex-vivo organ
perfusion and monitoring system indicated for the resuscitation,
preservation, and assessment of donor hearts with one or more of the
following characteristics for transplantation into a potential
recipient in a near-physiologic, normothermic, and beating state:
Expected cross-clamp or ischemic time >=4 hours due to donor
or recipient characteristics (e.g., donor-recipient geographical
distance, expected recipient surgical time)
Donor Age >=55 years
Donors with history cardiac arrest and downtime >=20 minutes
Donor history of alcohol use
Donor LV Ejection Fraction <=50 percent but >=40 percent
Donor history of Left Ventricular Hypertrophy (septal or
posterior wall thickness of >12 and <=16 millimeters)
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 https://www.fda.gov/advisory-committees/circulatory-system-devices-panel/2020-meeting-materials-circulatory-system-devices-panel. Select the link for the 2020 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 1, 2020. Oral presentations from the public will be scheduled
on October 7, 2020, 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
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participants, and an indication of the approximate time requested to
make their presentation on or before September 23, 2020. 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 September 25, 2020.
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 Ann Marie Williams at Annmarie.Williams@fda.hhs.gov 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-18259 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P