[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Pages 20888-20889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08198]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 6 and 7, 2014, from
8 a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is 301-977-8900.
Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301-796-3063, email:
[email protected], 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 Web site at http://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 coming to
the meeting.
Agenda: On May 6, 2014, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the RESQCPR System sponsored by Advanced
Circulatory Systems, Inc. The RESQCPR System is comprised of two
devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP
Active Compression Decompression CPR Device. These devices are used
together during manual cardiopulmonary resuscitation (CPR) in an
attempt to enhance venous return to the heart and blood flow to vital
organs during CPR to ultimately increase survival and neurologic
outcome in patients suffering from out of hospital cardiac arrest.
Advanced Circulatory Systems, Inc. has proposed the following
indications for use: the RESQCPR System is intended for use in the
performance of CPR to increase survival with favorable neurologic
function in adult patients with non-traumatic cardiac arrest.
On May 7, 2014, during session I, the committee will discuss and
make recommendations regarding the classification of membrane lung for
long-term pulmonary support systems, one of the remaining preamendment
Class III devices regulated under the 510(k) pathway. A membrane lung
for long-term pulmonary support refers to the oxygenator component of
an extracorporeal circuit used during long-term procedures, commonly
referred to as extracorporeal membrane oxygenation (ECMO). An ECMO
procedure provides assisted extracorporeal circulation and physiologic
gas exchange of a patient's blood when an acute (reversible) condition
prevents the patient's own body from providing the physiologic gas
exchange needed to sustain life. The circuit is comprised of multiple
device types, including, but not limited to, an oxygenator, blood pump,
cannulae, heat exchanger, tubing, filters, monitors/detectors, and
other accessories; the circuit components and configuration (e.g.,
arteriovenous, veno-venous) may differ based on the needs of the
individual patient or the condition being treated. ECMO is currently
used for patients with acute reversible respiratory or cardiac failure,
unresponsive to optimal ventilation and/or pharmacologic management.
On January 8, 2013 the FDA issued a proposed order which, if made
final, would make the class III ECMO devices class II subject to
premarket notification (510(k)) and special controls. FDA discussed the
regulatory history of ECMO devices as part of the proposed order. On
September 12, 2013, the classification of ECMO was discussed at a
meeting of the Circulatory System Devices Panel. The Panel agreed with
FDA's proposal to reclassify ECMO to class II (special controls) as
outlined in the January 8, 2013, proposed order, but recommended that a
panel be reconvened to discuss use of ECMO in an adult patient
population as the September 12, 2013, panel meeting was focused on the
use of ECMO in a pediatric patient population.
The discussion at this panel meeting will involve making
recommendations regarding regulatory classification to either reconfirm
to class III (subject to premarket approval application (PMA)) or
reclassify to class II and comment on whether special controls are
adequate to assure the safety and effectiveness of this device in an
adult patient population.
On May 7, 2014, during session II, the committee will discuss and
make recommendations regarding the classification of More-than-
Minimally Manipulated Allograft Heart Valves (MMM Allograft HVs). An
MMM Allograft HV is a human valve or valved-conduit that has been
aseptically recovered from qualified donors, dissected free from the
human heart, and then subjected to a manufacturing process(es) which
alters the original relevant characteristics of the tissue (cf. 21 CFR
1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then
stored until needed by a recipient. An
[[Page 20889]]
example of such a manufacturing process is one which intentionally
removes the cells and cellular debris, with the goal of reducing in
vivo antigenicity.
MMM Allograft HVs are considered preamendment devices because they
were found substantially equivalent to devices in commercial
distribution prior to May 28, 1976, when the Medical Device Amendments
became effective. MMM Allograft HVs are currently regulated under the
heading of ``Heart Valve, More than Minimally Manipulated Allograft'',
Product Code OHA, as unclassified devices and reviewed under the
premarket notification, 510(k), authority. FDA is seeking committee
input on the safety and effectiveness of MMM Allograft HVs and the
regulatory classification for MMM Allograft HVs.
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 Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
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
April 28, 2014. On May 6, oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. On May 7, oral
presentations from the public will be scheduled between approximately
9:30 a.m. and 10 a.m. for session I and between 2 p.m. and 2:30 p.m.
for session II. Those individuals interested in making formal oral
presentations should notify the contact person and submit 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 April 18, 2014. 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 April 21,
2014.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark,
Conference Management Staff, at [email protected] or 301-796-5293
at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://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: April 4, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-08198 Filed 4-11-14; 8:45 am]
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