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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.

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 April 6, 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:  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, [email protected], 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 April 6, 2021, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the TransMedics Organ Care System (OCS) Heart, by TransMedics, Inc.  The proposed Indication for Use for the TransMedics OCS Heart, is as follows:  The TransMedics Organ Care System (OCS) Heart System is a portable extracorporeal heart perfusion and monitoring system indicated for the resuscitation, preservation, and assessment of donor hearts in a near-physiologic, normothermic, and beating state intended for a potential transplant recipient. 

OCS Heart is indicated for donor hearts with one or more of the following characteristics:

• Expected cross-clamp or ischemic time ≥ 4 hours due to donor or recipient characteristics (e.g., donor- recipient geographical distance, expected recipient surgical time); or
• Expected total cross-clamp time of ≥ 2 hours PLUS one of the following risk factors:
• Donor Age ≥ 55 years; or
• Donors with history of cardiac arrest and downtime ≥ 20 minutes; or
• Donor history of alcoholism; or
• Donor history of diabetes; or
• Donor Left Ventricular Ejection Fraction ≤ 50 percent but ≥ 40 percent; or
• Donor history of Left Ventricular Hypertrophy (septal or posterior wall thickness of >12 and ≤ 16 mm); or
• Donor angiogram with luminal irregularities but no significant coronary artery disease.

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/2021-meeting-materials-circulatory-system-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 March 30, 2021.  Oral presentations from the public will be scheduled on April 6, 2021, 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 March 22, 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 March 23, 2021. 

For press inquiries, please contact the Office of Media Affairs at [email protected] 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 [email protected] 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:  February 25, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

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