[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Pages 49272-49274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19521]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-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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[[Page 49273]]

    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 September 11 and 12, 
2013, from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Montgomery Room, 
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel 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 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 September 11, 2013, during session I, the committee will 
discuss and make recommendations regarding the proposed classification 
of external cardiac compressor (ECC) devices, one of the remaining 
preamendments class III devices regulated under the section 510(k) of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
360(k)) (510(k)) pathway. ECCs, also known as chest compressors, assist 
in the act of cardiopulmonary resuscitation (CPR). The devices in this 
classification are divided into two types: (1) Devices that provide 
automatic chest compressions at a fixed compression rate and depth 
(automated ECCs), which are placed directly on the patient's chest and 
are powered manually, pneumatically, or electrically and (2) devices 
that aid the emergency medical professional in delivering manual 
compressions at a compression depth and rate that are consistent with 
current guidelines (CPR Aids). These devices are placed beneath the 
hands of the emergency medical professional or in the vicinity of the 
cardiac arrest victim and provide audio and/or visual feedback to 
assist emergency personnel in following the recommended steps for CPR 
and maintaining the recommended rate and depth of compressions for the 
duration of CPR.
    On January 8, 2013 (78 FR 1162), FDA issued a proposed order which, 
if made final, would make the class III ECC devices class II subject to 
special controls and, except as noted below, premarket notification 
(510(k)). The CPR aid device is proposed to be exempt from section 
510(k) of the FD&C Act if it is a prescription use device that provides 
feedback to the rescuer consistent with the current American Heart 
Association guidelines for CPR and in compliance with the special 
controls, subject to the limitations of exemptions in 21 CFR 870.9. The 
regulatory history of ECC devices has been discussed as part of the 
proposed rule (77 FR 36951, June 20, 2012).
    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. The committee will further be asked 
to comment on whether general and/or special controls are adequate to 
assure the safety and effectiveness of the device and whether, if 
reclassified to class II, these devices should be exempt from premarket 
notification requirements.
    On September 11, 2013, during session II, the committee will 
discuss and make recommendations regarding classification of external 
pacemaker pulse generators (EPPGs), one of the remaining preamendments 
class III devices regulated under the 510(k) pathway. An EPPG is a 
device that has a power supply and electronic circuits that produce a 
periodic electrical pulse to stimulate the heart. This device, which is 
used outside the body, is used as a temporary substitute for the 
heart's intrinsic pacing system until a permanent pacemaker can be 
implanted, or to control irregular heartbeats in patients following 
cardiac surgery or a myocardial infarction. The device may have 
adjustments for impulse strength, duration, R-wave sensitivity, and 
other pacing variables.
    On October 17, 2011 (76 FR 64224), FDA issued a proposed rule 
which, if made final, would make the class III external pacemaker pulse 
generator devices class II subject to premarket notification (510(k)) 
and special controls. The regulatory history of external pacemaker 
pulse generator devices has been discussed as part of the proposed rule 
(77 FR 36951).
    The discussion at the panel meeting will involve making 
recommendations regarding regulatory classification to either reconfirm 
to class III (subject to PMA) or reclassify to class II and comment on 
whether special controls are adequate to assure the safety and 
effectiveness of this device.
    Also during session II, FDA will be seeking feedback from the 
committee regarding classification of triple chamber pacing system 
analyzers (PSAs) with external pacing capability, a postamendments 
device classified through the premarket approval process as class III. 
A triple chamber PSA is intended to be used during the implant 
procedure of pacemakers and defibrillators, including biventricular 
devices, to evaluate the placement and integrity of pacing leads for 
determination of appropriate pacing parameters for the implanted 
device. The device provides pacing and sensing in up to three chambers 
during the implant procedure. The discussion at the panel meeting will 
involve making recommendations regarding regulatory classification to 
either reconfirm to class III (subject to PMA) or reclassify to class 
II and comment on whether special controls are adequate to assure the 
safety and effectiveness of this device.
    On September 12, 2013, the committee will discuss and make 
recommendations regarding the proposed classification of membrane lung 
for long-term pulmonary support systems, one of the remaining 
preamendments 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 an 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 intended for 
patients with acute reversible respiratory or cardiac failure,

[[Page 49274]]

unresponsive to optimal ventilation and/or pharmacologic management.
    On January 8, 2013 (78 FR 1158), 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. The regulatory 
history of ECMO devices has been discussed as part of the proposed rule 
(78 FR 1158).
    The discussion at the panel meeting will involve making 
recommendations regarding regulatory classification to either reconfirm 
to class III (subject to PMA) or reclassify to class II and comment on 
whether special controls are adequate to assure the safety and 
effectiveness of this device.
    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 
August 28, 2013. On September 11, 2013, 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. On 
September 12, 2013, oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. 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 August 20, 2013. 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 August 22, 2013.
    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 AnnMarie Williams, 
Conference Management Staff, at [email protected] 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 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: August 7, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-19521 Filed 8-12-13; 8:45 am]
BILLING CODE 4160-01-P