[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]


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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.

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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 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