[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66847-66848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27068]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 December 5 and 6, 2012,
from 8 a.m. to 6 p.m.
Location: Holiday Inn, Grand Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD. The hotel phone number is 301-948-8900.
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, 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 December 5, 2012, during session I, the committee will
discuss and make recommendations regarding the 515(i) order issued by
FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for the external
counter-pulsating (ECP) devices, one of the remaining pre-Amendment
Class III devices. These systems typically consist of a treatment
table, pressure cuffs and a controller. They are intended to provide
noninvasive circulatory support by applying external pressure to the
lower extremities during diastole to increase coronary perfusion
pressure, and releasing external pressure during systole to reduce left
ventricular workload.
On March 9, 1979 (44 FR 13426), FDA published a proposed rule for
classification of ECP devices as class III requiring premarket
approval. The Cardiovascular Device Classification Panel (the Panel)
recommended class III because the device is life supporting and
potentially hazardous to life or health even when used properly. In
addition, the Panel believed that sufficient information did not exist
to determine the adequacy of general controls or to establish standards
to provide a reasonable assurance of the safety and effectiveness of
the device. Subsequent to the proposed rule, in 1980, FDA classified
external counter-pulsating devices into class III after receiving no
comments on the proposed rule (45 FR 7966, February 5, 1980). In 1987,
FDA published a clarification by inserting language in the codified
language stating that no effective date had been established for the
requirement for premarket approval for ECP devices (52 FR 17737, May
11, 1987).
The discussion at the 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 I or class II (subject to premarket notification
[510(k)]), as directed by section 515(i) of the Federal Food, Drug and
Cosmetic Act.
On December 5, 2012, during session II, the committee will discuss
and make recommendations regarding the 515(i) order issued by FDA on
April 9, 2009 [Docket No. FDA-2009-M-0101], for Intra-aortic balloon
and control systems, one of the remaining pre-Amendment Class III
devices. Intra-aortic balloon pump (IABP) systems consist of an
inflatable balloon and a console which inflates in synchronization with
the cardiac cycle. During diastole, the balloon will inflate, creating
a rise in pressure in the aorta, thus increasing blood flow to the
coronary arteries and increasing myocardial oxygen supply. During
systole, deflation of the balloon causes a fall in pressure in the
aorta, which assists the left ventricle by reducing the pressure that
needs to be generated to achieve ejection through the aortic valve.
On March 9, 1979 (44 FR 13369), FDA published a proposed rule for
classification of IABP devices as class III requiring premarket
approval. The Panel recommended class III because the device is life
supporting and because the Panel believed that insufficient medical and
scientific information existed to establish a standard to assure the
safety and effectiveness of the device. The Panel also stated that
controversy exists as to whether the device is beneficial in many
situations in which it is used, and that it is difficult to use the
device safely and effectively. Subsequent to the proposed rule, in
1980, FDA classified IABP devices into class III after receiving no
comments on the proposed rule (45 FR 7939, February 5, 1980). In 1987,
FDA published a clarification by inserting language in the codified
language stating that no effective date had been established for the
requirement for premarket approval for IABP devices (52 FR 17736, May
11, 1987).
The discussion at the 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 I or class II (subject to premarket notification
[510(k)]), as directed by section 515(i) of the Federal Food, Drug and
Cosmetic Act.
On December 6, 2012, the committee will discuss and make
recommendations regarding the 515(i) order issued by FDA on April 9,
2009 [Docket No. FDA-2009-M-0101], for Nonroller-type cardiopulmonary
bypass blood pumps, one of the remaining pre-Amendment Class III
devices. A nonroller-type cardiopulmonary bypass blood pump is a device
that uses a method other than revolving rollers to pump blood. There
are two types of
[[Page 66848]]
nonroller-type pumps which have been reviewed by the Agency: (1)
Centrifugal type pumps utilize a rotor to impart energy to the blood in
an extracorporeal circuit through centrifugal forces. These pumps are
part of an extracorporeal circuit usually containing an oxygenator and
are intended to provide cardiopulmonary support, during procedures such
as cardiopulmonary bypass surgery, for periods lasting 6 hours or less.
(2) Micro-axial type pumps are comprised of a pump motor, a cannula and
a catheter that connects to a console. These pumps are not designed to
be used with an oxygenator but are temporarily placed within the heart
or vasculature to provide cardiac support only.
On March 9, 1979 (44 FR 13409), FDA published a proposed rule for
classification of nonroller-type cardiopulmonary bypass blood pumps as
class III requiring premarket approval. The Panel recommended class III
because the device is life sustaining and life supporting and is
potentially hazardous to life or health even when properly used. The
Panel indicated that general controls alone would not provide
sufficient control over the performance characteristics of the device,
and that a performance standard would not provide reasonable assurance
of the safety and effectiveness of the device and, moreover, that there
was not sufficient information to establish a performance standard.
Consequently, the Panel believed that premarket approval was necessary
to assure the safety and effectiveness of the device. Subsequent to the
proposed rule, in 1980, FDA classified nonroller-type cardiopulmonary
bypass blood pumps into class III after receiving no comments on the
proposed rule (45 FR 7959, February 5, 1980). In 1987, FDA published a
clarification by inserting language in the codified language stating
that no effective date had been established for the requirement for
premarket approval for nonroller-type cardiopulmonary bypass blood
pumps (52 FR 17737, May 11, 1987).
In 1993, FDA published a proposed rule requiring filing a PMA or
Product Development Protocol (PDP) for nonroller type cardiopulmonary
bypass blood pumps, and provided an opportunity to request a change in
classification in the form of a reclassification petition (58 FR 36290,
July 6, 1993). On July 21, 1993, FDA received a reclassification
petition from manufacturers of these devices recommending
reclassification to Class II (special controls). In 1995, FDA convened
the Panel to review the proposed reclassification and proposed special
controls for nonroller-type cardiopulmonary blood pumps for use in
cardiopulmonary bypass circuits for periods of up to six hours. Micro-
axial type pumps as described previously were not included in the scope
of the reclassification. Reclassification to Class II with special
controls was supported by the Panel for nonroller-type cardiopulmonary
blood pumps for use in cardiopulmonary bypass circuits for periods of
up to six hours, but FDA did not issue a regulation codifying the
proposed reclassification. In 2004, the July 6, 1993 proposed rule (58
FR 36290) was withdrawn because the proposed rule was no longer
considered a viable candidate for final action (69 FR 68831, November
26, 2004).
The discussion at the 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 I or class II (subject to premarket notification
[510(k)]), as directed by section 515(i) of the Federal Food, Drug and
Cosmetic Act.
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
November 26, 2012. 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 November 13, 2012. 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 November 14, 2012.
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: October 31, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-27068 Filed 11-6-12; 8:45 am]
BILLING CODE 4160-01-P