Premarket Notification Submission 5100(k), Subpart E

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(l) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) AMOCs: The Manager, International
Branch, ANM–116, Transport Airplane
Directorate, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
In accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the International Branch, send it to ATTN:
Tom Rodriguez, Aerospace Engineer,
International Branch; ANM–116, Transport
Airplane Directorate, FAA, 1601 Lind
Avenue SW., Renton, Washington 98057–
3356; telephone 425–227–1137; fax 425–227–
1137. Information may be emailed to: [email protected].
Before using any approved AMOC, notify
your appropriate principal inspector, or
lacking a principal inspector, the manager of
the local flight standards district office/
certificate holding district office. The AMOC
approval letter must specifically reference
this AD.
(2) Airworthy Product: For any requirement
in this AD to obtain corrective actions from
a manufacturer or other source, use these
actions if they are FAA-approved. Corrective
actions are considered FAA-approved if they
are approved by the State of Design Authority
(or their delegated agent). You are required
to assure the product is airworthy before it
is returned to service.
(m) Related Information
(1) Refer to MCAI EASA Airworthiness
Directive 2012–0189, dated September 24,
2012, and the following service information
for related information.
(i) Dassault Mandatory Service Bulletin
F20–785, dated June 11, 2012.
(ii) Dassault Mandatory Service Bulletin
F200–131, dated June 11, 2012.
(iii) Dassault Aviation Maintenance
Procedure 26–20–2, ‘‘Removal of
Pyrotechnical Cartridge for Check/
Replacement,’’ dated October 2010, of
Chapter 26 of Book 2 of the Falcon 20
Maintenance Manual.
(iv) Dassault Maintenance Procedure 26–
20–3, ‘‘Weighing of Engine Freon Fire
Extinguishers,’’ dated October 2009, of
Chapter 26 of Book 2 of the Falcon 20
Maintenance Manual.
(v) Dassault Aviation Falcon 200
Maintenance Requirement Card 171.0,
‘‘Engine/Rear compartment Extinguisher
(14W1–14W2)—Removal/Installation (ATA
26–20–06),’’ dated December 2011, of
Chapter 26 of Book 1 of the Falcon 200
Maintenance Manual.
(vi) Dassault Aviation Falcon 200
Maintenance Requirement Card 171.0,
‘‘Engine/Rear compartment Extinguisher
(14W1–14W2)—Check/Replacement of
Percussion Cartridge (ATA 26–20–08),’’
dated December 2011, of Chapter 26 of Book
1 of the Falcon 200 Maintenance Manual.
(2) For service information identified in
this AD, contact Dassault Falcon Jet, P.O. Box
2000, South Hackensack, NJ 07606;
telephone 201–440–6700; Internet http://
www.dassaultfalcon.com. You may review

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copies of the referenced service information
at the FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, WA. For
information on the availability of this
material at the FAA, call 425–227–1221.
Issued in Renton, Washington, on May 13,
2013.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 2013–12077 Filed 5–20–13; 8:45 am]
BILLING CODE 4910–13–P

DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
18 CFR Part 35
[Docket No. RM13–2–000]

Small Generator Interconnection
Agreements and Procedures
Federal Energy Regulatory
Commission.
ACTION: Notice of Proposed Rulemaking;
correction.
AGENCY:

SUMMARY: This document contains
corrections to the proposed rule (RM13–
2–000) which was published in the
Federal Register of Friday, February 1,
2013 (78 FR 7524). The regulations
revised the pro forma Small Generator
Interconnection Procedures (SGIP) and
pro forma Small Generator
Interconnection Agreement (SGIA)
originally set forth in Order No. 2006.
DATES: Effective on [June 3, 2013].
FOR FURTHER INFORMATION CONTACT:
Leslie Kerr (Technical Information),
Office of Energy Policy and
Innovation, Federal Energy Regulatory
Commission, 888 First Street NE.,
Washington, DC 20426, (202) 502–
8540, [email protected].
Monica Taba (Technical Information),
Office of Electric Reliability, Federal
Energy Regulatory Commission, 888
First Street NE., Washington, DC
20426, (202) 502–6789,
[email protected].
Elizabeth Arnold (Legal Information),
Office of the General Counsel, Federal
Energy Regulatory Commission, 888
First Street NE., Washington, DC
20426, (202) 502–8687,
[email protected].
SUPPLEMENTARY INFORMATION:

Errata Notice
On January 17, 2013, the Commission
issued an order in the above-referenced
docket. Small Generator Interconnection
Agreements and Procedures, 142 FERC
¶ 61,049 (2013). The order is revised as
follows:

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The fourth sentence of paragraph 45
should read, ‘‘This requirement was
included in Order No. 2006 62 but was
not made clear in the pro forma SGIP.’’
Footnote 62 should read, ‘‘Order No.
2006, FERC Stats. & Regs. ¶ 31,180 at P
140.’’
In FR Doc. 2013–01366 appearing on
page 7523 in the Federal Register of
Friday, February 1, 2013, the same
corrections are made:
1. On page 7531, the fourth sentence
of paragraph 45 should read, ‘‘This
requirement was included in Order No.
2006 62 but was not made clear in the
pro forma SGIP.’’
2. On page 7531, Footnote 62 should
read, ‘‘Order No. 2006, FERC Stats. &
Regs. ¶ 31,180 at P 140.’’
Dated: April 25, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013–12079 Filed 5–20–13; 8:45 am]
BILLING CODE 6717–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2013–N–0487]

Cardiovascular Devices;
Reclassification of External CounterPulsating Devices for Treatment of
Chronic Stable Angina; Effective Date
of Requirement for Premarket
Approval for External CounterPulsating Devices for Other Specified
Intended Uses
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Proposed order.

SUMMARY: The Food and Drug
Administration (FDA) is issuing a
proposed administrative order to
reclassify external counter-pulsating
(ECP) devices for treatment of chronic
stable angina that is refractory to
optimal anti-anginal medical therapy
and without options for
revascularization, which is a
preamendments class III device, into
class II (special controls) based on new
information. FDA is also proposing to
require the filing of a premarket
approval application (PMA) or a notice
of completion of a product development
protocol (PDP) for ECP devices for other
intended uses specified in this proposed
order. The Agency is also summarizing
its proposed findings regarding the
degree of risk of illness or injury
designed to be eliminated or reduced by

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Federal Register / Vol. 78, No. 98 / Tuesday, May 21, 2013 / Proposed Rules
requiring the devices to meet the
statute’s approval requirements for other
intended uses specified in this proposed
order. In addition, FDA is announcing
the opportunity for interested persons to
request that the Agency change the
classification of any of the devices
mentioned in this document based on
new information. This action
implements certain statutory
requirements.
Submit either electronic or
written comments on this proposed
order by August 19, 2013. FDA intends
that, if a final order based on this
proposed order is issued, anyone who
wishes to continue to market ECP
devices for specified intended uses
listed in section IX will need to file a
PMA or a notice of completion of a PDP
within 90 days of the effective date of
the final order. See section XVII for the
proposed effective date of any final
order based on this proposed order.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2013–N–
0487, by any of the following methods:
DATES:

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.

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Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2013–N–0487 for this
rulemaking. All comments received may
be posted without change to http://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section.
Docket: For access to the docket to
read background documents or
comments received, go to http://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Angela Krueger, Center for Devices and
Radiological Health, Food and Drug

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Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring,
MD 20993, 301–796–6380,
[email protected].
SUPPLEMENTARY INFORMATION:

I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105–115), the
Medical Device User Fee and
Modernization Act of 2002 (Public Law
107–250), the Medical Devices
Technical Corrections Act (Pub. L. 108–
214), the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85), and the Food and Drug
Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112–144),
establishes a comprehensive system for
the regulation of medical devices
intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c)
established three categories (classes) of
devices, reflecting the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513 of the FD&C Act,
devices that were in commercial
distribution before the enactment of the
1976 amendments, May 28, 1976
(generally referred to as preamendments
devices), are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
FDA has classified most
preamendments devices under these
procedures.
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
postamendments devices), are
automatically classified by section
513(f) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless, and
until, the device is reclassified into class
I or II or FDA issues an order finding the
device to be substantially equivalent, in
accordance with section 513(i) of the
FD&C Act, to a predicate device that
does not require premarket approval.
The Agency determines whether new

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devices are substantially equivalent to
predicate devices by means of
premarket notification procedures in
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part
807).
A preamendments device that has
been classified into class III and devices
found substantially equivalent by means
of premarket notification (510(k))
procedures to such a preamendments
device or to a device within that type
may be marketed without submission of
a PMA until FDA issues a final order
under section 515(b) of the FD&C Act
(21 U.S.C. 360e(b)) requiring premarket
approval or until the device is
subsequently reclassified into class I or
class II.
Although, under the FD&C Act, the
manufacturer of class III
preamendments device may respond to
the call for PMAs by filing a PMA or a
notice of completion of a PDP, in
practice, the option of filing a notice of
completion of a PDP has not been used.
For simplicity, although corresponding
requirements for PDPs remain available
to manufacturers in response to a final
order under section 515(b) of the FD&C
Act, this document will refer only to the
requirement for the filing and receiving
approval of a PMA.
On July 9, 2012, FDASIA was enacted.
Section 608(a) of FDASIA (126 Stat.
1056) amended section 513(e) of the
FD&C Act, changing the process for
reclassifying a device from rulemaking
to an administrative order. Section
608(b) of FDASIA (126 Stat. 1056)
amended section 515(b) of the FD&C
Act, changing the process for requiring
premarket approval for a
preamendments class III device from
rulemaking to an administrative order.
A. Reclassification
FDA is publishing this document to
propose the reclassification of ECP
devices for treatment of chronic stable
angina that is refractory to optimal antianginal medical therapy and without
options for revascularization from class
III to class II.
Section 513(e) of the FD&C Act
governs reclassification of classified
preamendments devices. This section
provides that FDA may, by
administrative order, reclassify a device
based upon ‘‘new information.’’ FDA
can initiate a reclassification under
section 513(e) of the FD&C Act or an
interested person may petition FDA to
reclassify a preamendments device. The
term ‘‘new information,’’ as used in
section 513(e) of the FD&C Act, includes
information developed as a result of a
reevaluation of the data before the
Agency when the device was originally

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classified, as well as information not
presented, not available, or not
developed at that time. (See, e.g.,
Holland-Rantos Co. v. United States
Department of Health, Education, and
Welfare, 587 F.2d 1173, 1174 n.1 (D.C.
Cir. 1978); Upjohn v. Finch, 422 F.2d
944 (6th Cir. 1970); Bell v. Goddard, 366
F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously
before the Agency is an appropriate
basis for subsequent action where the
reevaluation is made in light of newly
available authority (see Bell, 366 F.2d at
181; Ethicon, Inc. v. FDA, 762 F.Supp.
382, 388–391 (D.D.C. 1991)), or in light
of changes in ‘‘medical science’’
(Upjohn, 422 F.2d at 951). Whether data
before the Agency are old or new data,
the ‘‘new information’’ to support
reclassification under section 513(e)
must be ‘‘valid scientific evidence,’’ as
defined in section 513(a)(3) of the FD&C
Act and § 860.7(c)(2) (21 CFR
860.7(c)(2)). (See, e.g., General Medical
Co. v. FDA, 770 F.2d 214 (D.C. Cir.
1985); Contact Lens Association v. FDA,
766 F.2d 592 (D.C. Cir.), cert. denied,
474 U.S. 1062 (1985).)
FDA relies upon ‘‘valid scientific
evidence’’ in the classification process
to determine the level of regulation for
devices. To be considered in the
reclassification process, the ‘‘valid
scientific evidence’’ upon which the
Agency relies must be publicly
available. Publicly available information
excludes trade secret and/or
confidential commercial information,
e.g., the contents of a pending PMA.
(See section 520(c) of the FD&C Act (21
U.S.C. 360j(c)).) Section 520(h)(4) of the
FD&C Act, added by FDAMA, provides
that FDA may use, for reclassification of
a device, certain information in a PMA
6 years after the application has been
approved. This can include information
from clinical and preclinical tests or
studies that demonstrate the safety or
effectiveness of the device but does not
include descriptions of methods of
manufacture or product composition
and other trade secrets.
Section 513(e)(1) of the FD&C Act sets
forth the process for issuing a final
order. Specifically, prior to the issuance
of a final order reclassifying a device,
the following must occur: (1)
Publication of a proposed order in the
Federal Register; (2) a meeting of a
device classification panel described in
section 513(b) of the FD&C Act; and (3)
consideration of comments to a public
docket. FDA has held a meeting of a
device classification panel described in
section 513(b) of the FD&C Act with
respect to external-counter pulsating
devices, and therefore, has met this

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requirement under section 515(b)(1) of
the FD&C Act.
FDAMA added section 510(m) to the
FD&C Act. Section 510(m) of the FD&C
Act provides that a class II device may
be exempted from the premarket
notification requirements under section
510(k) of the FD&C Act, if the Agency
determines that premarket notification
is not necessary to assure the safety and
effectiveness of the device.
B. Requirement for Premarket Approval
Application
FDA is proposing to require PMAs for
ECP devices for Certain Specified
Intended Uses.1
Section 515(b)(1) of the FD&C Act sets
forth the process for issuing a final
order. Specifically, prior to the issuance
of a final order requiring premarket
approval for a preamendments class III
device, the following must occur: (1)
Publication of a proposed order in the
Federal Register; (2) a meeting of a
device classification panel described in
section 513(b) of the FD&C Act; and (3)
consideration of comments from all
affected stakeholders, including
patients, payors, and providers. FDA
has held a meeting of a device
classification panel described in section
513(b) of the FD&C Act with respect to
external-counter pulsating devices, and
therefore, has met this requirement
under section 515(b)(1) of the FD&C Act.
Section 515(b)(2) of the FD&C Act
provides that a proposed order to
require premarket approval shall
contain: (1) The proposed order, (2)
proposed findings with respect to the
degree of risk of illness or injury
designed to be eliminated or reduced by
1 For the purposes of this proposed order, the
term ‘‘Certain Specified Intended Uses’’ includes
the following intended uses:
• Unstable angina pectoris;
• Acute myocardial infarction;
• Cardiogenic shock;
• Congestive heart failure;
• Postoperative treatment of patients who have
undergone coronary artery bypass surgery;
• Peripheral arterial disease associated with the
following: Ischemic ulcers rest pain or claudication;
threatened gangrene; insufficient blood supply at an
amputation site; persisting ischemia after
embolectomy or bypass surgery; and/or pre- and
post-arterial reconstruction to improve runoff;
• Diabetes complicated by peripheral arterial
disease or other conditions possibly related to
arterial insufficiency including the following:
Nocturnal leg cramps and/or necrobiosis
diabeticorum;
• Venous diseases, including the following:
Prophylaxis of deep vein thrombophlebitis; edema
(e.g., chronic lymphedema) and/or induration (e.g.,
stasis dermatitis) associated with chronic venous
stasis; venous stasis ulcers; and/or
thrombophlebitis;
• Athletic injuries, including the following:
Charley horses, pulled muscles, and/or edematous
muscles; and
• Necrotizing cellulitis.

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requiring the device to have an
approved PMA or a declared completed
PDP and the benefit to the public from
the use of the device, (3) an opportunity
for the submission of comments on the
proposed order and the proposed
findings, and (4) an opportunity to
request a change in the classification of
the device based on new information
relevant to the classification of the
device.
Section 515(b)(3) of the FD&C Act
provides that FDA shall, after the close
of the comment period on the proposed
order, consideration of any comments
received, and a meeting of a device
classification panel described in section
513(b) of the FD&C Act, issue a final
order to require premarket approval or
publish a document terminating the
proceeding together with the reasons for
such termination. If FDA terminates the
proceeding, FDA is required to initiate
reclassification of the device under
section 513(e) of the FD&C Act, unless
the reason for termination is that the
device is a banned device under section
516 of the FD&C Act (21 U.S.C. 360f)
A preamendments class III device
may be commercially distributed
without a PMA until 90 days after FDA
issues a final order (a final rule issued
under section 515(b) of the FD&C Act
prior to the enactment of FDASIA is
considered to be a final order for
purposes of section 501(f) of the FD&C
Act (21 U.S.C. 351(f))) requiring
premarket approval for the device, or 30
months after final classification of the
device under section 513 of the FD&C
Act, whichever is later. For ECP devices,
the preamendments class III devices that
are the subject of this proposal, the later
of these two time periods is the 90-day
period. Since these devices were
classified in 1980, the 30-month period
has expired (45 FR 7966; February 5,
1980). Therefore, if the proposal to
require premarket approval for ECP
devices for Certain Specified Intended
Uses is finalized, section 501(f)(2)(B) of
the FD&C Act requires that a PMA for
such device be filed within 90 days of
the date of issuance of the final order.
If a PMA is not filed for such device
within 90 days after the issuance of a
final order, the device would be deemed
adulterated under section 501(f) of the
FD&C Act.
Also, a preamendments device subject
to the order process under section
515(b) of the FD&C Act is not required
to have an approved investigational
device exemption (IDE) (see part 812 (21
CFR part 812)) contemporaneous with
its interstate distribution until the date
identified by FDA in the final order
requiring the filing of a PMA for the
device. At that time, an IDE is required

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only if a PMA has not been filed. If the
manufacturer, importer, or other
sponsor of the device submits an IDE
application and FDA approves it, the
device may be distributed for
investigational use. If a PMA is not filed
by the later of the two dates, and the
device is not distributed for
investigational use under an IDE, the
device is deemed to be adulterated
within the meaning of section
501(f)(1)(A) of the FD&C Act, and
subject to seizure and condemnation
under section 304 of the FD&C Act (21
U.S.C. 334) if its distribution continues.
Other enforcement actions include, but
are not limited to, the following:
Shipment of devices in interstate
commerce will be subject to injunction
under section 302 of the FD&C Act (21
U.S.C. 332), and the individuals
responsible for such shipment will be
subject to prosecution under section 303
of the FD&C Act (21 U.S.C. 333). In the
past, FDA has requested that
manufacturers take action to prevent the
further use of devices for which no PMA
has been filed and may determine that
such a request is appropriate for the
class III devices that are the subject of
this proposed order, if finalized.
In accordance with section 515(b)(2)
of the FD&C Act, interested persons are
being offered the opportunity to request
reclassification of ECP devices for
Certain Specified Intended Uses.
II. Regulatory History of the Device
In the preamble to the proposed rule
(44 FR 13426, March 9, 1979), the
Cardiovascular Device Classification
Panel (the 1979 Panel) recommended
that ECP devices be classified into class
III because the device is life-supporting
and is potentially hazardous to life or
health even when properly used. The
1979 Panel noted that the device
surrounds the limbs to which it is
attached, is in direct contact with the
skin, and is used in a clinical
environment where excessive leakage
current can be a serious hazard. As a
result the electrical characteristics of
this device need to meet certain
requirements. The 1979 Panel further
noted that the performance
characteristics, including accuracy,
reproducibility, and any limitations on
the device’s cardiac synchronization
and pressure application should be
maintained at a generally accepted
satisfactory level and should be made
known to the user through special
labeling. In addition, the device is used
with other devices in a system that may
be hazardous if not satisfactorily
assembled, used, and maintained. The
1979 Panel indicated that general
controls alone would not provide

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sufficient control over the performance
characteristics of the device, and that
there was not sufficient information to
establish a performance standard to
provide assurance of the safety and
effectiveness of the device.
Consequently, the 1979 Panel believed
that premarket approval was necessary
to assure the safety and effectiveness of
the device. 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 codifying a statement that no
effective date had been established for
the requirement for premarket approval
for external counter-pulsating devices
(52 FR 17732 at 17737, May 11, 1987).
In 2009, FDA published an order for
the submission of information on
external counter-pulsating devices by
August 7, 2009 (74 FR 16214, April 9,
2009). FDA received five responses to
that order from device manufacturers
recommending that ECP devices be
reclassified to class II. The
manufacturers stated that safety and
effectiveness of these devices may be
assured by device design, performance
testing, and labeling (special controls).
As explained further in sections VII
and XI, a meeting of the Circulatory
System Devices Panel (the 2012 Panel)
took place December 5, 2012, to discuss
whether ECP devices should be
reclassified or remain in class III. The
2012 Panel recommended that ECP
devices intended for treatment of
chronic stable angina that is refractory
to optimal anti-anginal medical therapy
and without options for
revascularization be reclassified to class
II with special controls and ECP devices
for Certain Specified Intended Uses
remain in class III. Because the safety
and effectiveness of ECP devices for
Certain Specified Intended Uses has not
been established through adequate
scientific evidence, the device presents
a potential unreasonable risk of injury
given that the benefit of ECP devices for
these uses is unknown. In addition,
there was insufficient information to
establish special controls for these uses.
FDA is not aware of new information
that would provide a basis for a
different recommendation or findings.
III. Device Description
An external counter-pulsating device
is a noninvasive device used to assist
the heart by applying positive or
negative pressure to one or more of the
body’s limbs in synchrony with the
heart cycle. An ECP system typically
consists of a treatment table, a set of
pressure cuffs, and a control console.

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The control console controls a
pneumatic circuit that inflates and
deflates the pressure cuffs. The
inflatable pressure cuffs are wrapped
around the calves, the lower and upper
thighs, and/or the buttocks. They are
rapidly and sequentially inflated,
starting from the calves and moving
proximally during the diastolic phase of
a cardiac cycle. This creates an arterial
retrograde flow of blood towards the
heart and increases blood flow to the
coronary arteries at a time when
resistance to the coronary blood flow is
low. The inflation of the cuffs also
simultaneously increases the volume of
venous blood returned to the right side
of the heart, providing greater filling of
the ventricle for ejection. The
synchronization between the cardiac
cycle and the inflation/deflation cycle of
the cuffs is coordinated by custom
software contained within the control
console that monitors and interprets the
patient’s electrocardiogram and heart
rhythm.
IV. Proposed Reclassification
FDA is proposing that ECP devices for
treatment of chronic stable angina that
is refractory to optimal anti-anginal
medical therapy and without options for
revascularization be reclassified from
class III to class II. In this proposed
order, the Agency has identified special
controls under section 513(a)(1)(B) of
the FD&C Act that, together with general
controls applicable to the devices,
would provide reasonable assurance of
their safety and effectiveness. Absent
the special controls identified in this
proposed order, general controls
applicable to the device are insufficient
to provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, in accordance with
sections 513(e) and 515(i) of the FD&C
Act and § 860.130, based on new
information with respect to the devices
and taking into account the public
health benefit of the use of the device
and the nature and known incidence of
the risk of the device, FDA, on its own
initiative, is proposing to reclassify this
preamendments class III device into
class II for the treatment of chronic
stable angina that is refractory to
optimal anti-anginal medical therapy
and without options for
revascularization. FDA believes that this
new information is sufficient to
demonstrate that the proposed special
controls can effectively mitigate the
risks to health identified in the next
section, and that these special controls,
together with general controls, will
provide a reasonable assurance of safety
and effectiveness for ECP devices for
treatment of chronic stable angina that

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is refractory to optimal anti-anginal
medical therapy and without options for
revascularization.
Section 510(m) of the FD&C Act
authorizes the Agency to exempt class II
devices from premarket notification
(510(k)) submission. FDA has
considered ECP devices for treatment of
chronic stable angina that is refractory
to optimal anti-anginal medical therapy
and without options for
revascularization in accordance with the
reserved criteria set forth in section
513(a) of the FD&C Act and decided that
the device does require premarket
notification. Therefore, the Agency does
not intend to exempt this proposed class
II device from premarket notification
(510(k)) submission.

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V. Risks to Health
After considering available
information, including the
recommendations of the advisory
committees (panels) for the
classification of these devices, FDA has
evaluated the risks to health associated
with the use of ECP devices and
determined that the following risks to
health are associated with its use:
• Cardiac arrhythmias—Excessive
electrical leakage current may disturb
the normal electrophysiology of the
heart, leading to the onset of cardiac
arrhythmias.
• Trauma/Irritation to the limb—
Improper mechanical design, including
selection of materials, may cause
bruising, blistering, muscle aches, and/
or pain to the limb(s).
• Ineffective cardiac assistance—
Improper timing or failure to
synchronize the device with the
appropriate phase of the cardiac cycle
may lead to ineffective cardiac
assistance by the device.
VI. Summary of Reasons for
Reclassification
If properly manufactured and used,
ECP devices can provide a treatment
option for patients with chronic stable
angina that is refractory to optimal antianginal medical therapy and without
options for revascularization, especially
patients who are not candidates for
treatment by revascularization and who
are refractory to medical therapy, by
increasing blood flow to the coronary
arteries and increasing the volume of
venous blood returned to the right side
of the heart, providing greater filling of
the ventricle for ejection. FDA believes
that ECP devices intended for treatment
of chronic stable angina that is
refractory to optimal anti-anginal
medical therapy and without options for
revascularization should be reclassified
from class III to class II because special

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controls, in addition to general controls,
can be established to provide reasonable
assurance of the safety and effectiveness
of the device, and because general
controls themselves are insufficient to
provide reasonable assurance of its
safety and effectiveness. In addition,
there is now adequate effectiveness
information sufficient to establish
special controls to provide such
assurance.
VII. Summary of Data Upon Which the
Reclassification Is Based
Since the time of the 1979 Panel
recommendation, sufficient evidence
has been developed to support a
reclassification of ECP devices to class
II with special controls for the treatment
of chronic stable angina that is
refractory to optimal anti-anginal
medical therapy and without options for
revascularization. FDA has been
reviewing these devices for many years
and their risks are well known. FDA
conducted a comprehensive review of
available literature for ECP devices for
treatment of chronic stable angina.
FDA’s review found 4 randomized
controlled trials (Refs. 1 to 4), 21
observational studies, and a metaanalysis of 13 individual studies that
provided consistent evidence of the
effectiveness of ECP devices for the
treatment of chronic stable angina that
is refractory to optimal anti-anginal
medical therapy and without options for
revascularization. Although all of the
studies of ECP for the treatment of
angina considered individually have
various limitations, the consistency of
the study results, the wide range of
angina-related endpoints involved in
the studies, the large magnitude of the
demonstrated beneficial outcomes, the
long duration (up to 3 years) of some of
the beneficial outcomes, and the fact
that many or most of the subjects had a
disease that was refractory to the effects
of any other treatment, all support a
conclusion of reasonable evidence for
the effectiveness of ECP in the treatment
of chronic stable angina that is
refractory to optimal anti-anginal
medical therapy and without options for
revascularization. The safety profile of
ECP devices has been established based
on the few relevant adverse events
reported in the literature or through
FDA’s Manufacturer and User Facility
Device Experience (MAUDE) database.
In addition, bench studies designed to
demonstrate the devices’ ability to
function as intended have been well
characterized.
The 2012 Panel discussed and made
recommendations regarding the
regulatory classification of ECP devices
to either reconfirm to class III (subject

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to premarket approval application) or
reclassify to class II (subject to special
controls) as directed by section 515(i) of
the FD&C Act.
FDA’s presentation to the 2012 Panel
included a summary of the available
safety and effectiveness information for
ECP devices for treatment of chronic
stable angina that is refractory to
optimal anti-anginal medical therapy
and without options for
revascularization, including adverse
event reports from the MAUDE database
and available literature. Based on the
available scientific literature that
supports that ECP may be beneficial for
patients with chronic stable angina who
are not revascularization candidates and
who are refractory to optimal medical
therapy, FDA recommended to the 2012
Panel that ECP devices for treatment of
chronic stable angina that is refractory
to optimal anti-anginal medical therapy
and without options for
revascularization be reclassified to class
II (special controls). The 2012 Panel
agreed with FDA’s conclusion that the
available scientific evidence is adequate
to support the safety and effectiveness
of ECP devices for treatment of chronic
stable angina that is refractory to
optimal anti-anginal medical therapy
and without options for
revascularization.
The 2012 Panel also agreed with the
identified risks to health outlined in
section V. FDA recommended that a
fourth risk to health, failure to identify
the correct patient population, be
considered in the 2012 Panel’s
deliberations. FDA proposed this risk to
health to capture situations in which the
device was used properly but patients
experienced adverse events associated
with their underlying comorbidities. For
example, based on FDA’s evaluation of
Medical Device Reporting Regulations
more than half were associated with
patients with congestive heart failure
who experience exacerbation of the
condition following use of the device.
However, the 2012 Panel questioned
whether failure to identify the correct
patient population was really a risk to
health and noted that the risk is vague
and too broad. FDA agreed with the
2012 Panel’s recommendation and
removed the proposed fourth risk. The
2012 Panel agreed with FDA’s proposed
special controls outlined in section VIII.
In addition, the 2012 Panel also agreed
with FDA that ECP devices are not
considered to be life-supporting. This
differs from the 1979 Panel’s
recommendation outlined in the
proposed rule for this device type (44
FR 13426, March 9, 1979). The 2012
Panel transcript and other meeting

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materials are available on FDA’s Web
site (Ref. 5).

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VIII. Proposed Special Controls
FDA believes that the following
special controls, together with general
controls, are sufficient to mitigate the
risks to health described in section V:
(1) Nonclinical performance
evaluation of the device must
demonstrate a reasonable assurance of
safety and effectiveness for applied
pressure, synchronization of therapy
with the appropriate phase of the
cardiac cycle, and functionality of
alarms during a device malfunction or
an abnormal patient condition;
(2) Reliabilities of the mechanical and
electrical systems must be established
through bench testing under simulated
use conditions and matched by
appropriate maintenance schedules;
(3) Software design and verification
and validation must be appropriately
documented;
(4) The skin-contacting components of
the device must be demonstrated to be
biocompatible;
(5) Appropriate analysis and testing
must be conducted to verify electrical
safety and electromagnetic compatibility
of the device; and
(6) Labeling must bear all information
required for the safe and effective use of
the device, including a detailed
summary of the device-related and
procedure-related complications
pertinent to use of the device.
ECP devices are prescription devices
restricted to patient use only upon the
authorization of a practitioner licensed
by law to administer or use the device.
(Proposed § 870.5225(a) (21 CFR
870.5225(a)); see section 520(e) of the
FD&C Act and 21 CFR 801.109
(Prescription devices)). Prescription-use
requirements are a type of general
control authorized under section 520(e)
of the FD&C Act and defined as a
general control in section 513(a)(1)(A)(i)
of the FD&C Act; and under § 807.81,
the device would continue to be subject
to 510(k) notification requirements.
IX. Dates New Requirements Apply
In accordance with section 515(b) of
the FD&C Act, FDA is proposing to
require that a PMA be filed with the
Agency within 90 days after issuance of
any final order based on this proposal
for ECP devices intended for the
following uses (Certain Specified
Intended Uses):
• Unstable angina pectoris;
• Acute myocardial infarction;
• Cardiogenic shock;
• Congestive heart failure;
• Postoperative treatment of patients
who have undergone coronary artery
bypass surgery;

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• Peripheral arterial disease
associated with the following: Ischemic
ulcers rest pain or claudication,
threatened gangrene, insufficient blood
supply at an amputation site, persisting
ischemia after embolectomy or bypass
surgery, and/or pre and post-arterial
reconstruction to improve runoff;
• Diabetes complicated by peripheral
arterial disease or other conditions
possibly related to arterial insufficiency
including the following: Nocturnal leg
cramps and/or necrobiosis
diabeticorum;
• Venous diseases, including the
following: Prophylaxis of deep vein
thrombophlebitis, edema (e.g., chronic
lymphedema) and/or induration (e.g.,
stasis dermatitis) associated with
chronic venous stasis, venous stasis
ulcers, and/or thrombophlebitis;
• Athletic injuries, including the
following: Charley horses, pulled
muscles, and/or edematous muscles;
and
• Necrotizing cellulitis.
An applicant whose device was
legally in commercial distribution
before May 28, 1976, or whose device
has been found to be substantially
equivalent to such a device, will be
permitted to continue marketing such
class III devices during FDA’s review of
the PMA provided that the PMA is
timely filed. FDA intends to review any
PMA for the device within 180 days of
the date of filing. FDA cautions that
under section 515(d)(1)(B)(i) of the
FD&C Act, the Agency may not enter
into an agreement to extend the review
period for a PMA beyond 180 days
unless the Agency finds that ‘‘the
continued availability of the device is
necessary for the public health.’’
An applicant whose device was
legally in commercial distribution
before May 28, 1976, or whose device
has been found to be substantially
equivalent to such a device, who does
not intend to market such device for any
one or more Certain Specified Intended
Uses, may remove such intended uses
from the device’s labeling by initiating
a correction within 90 days after
issuance of any final order based on this
proposal. 21 CFR 806.10(a)(2) requires a
device manufacturer or importer
initiating a correction to remedy a
violation of the FD&C Act that may
present a risk to health to submit a
written report of the correction to FDA.
FDA intends that under § 812.2(d), the
preamble to any final order based on
this proposal will state that, as of the
date on which the filing of a PMA is
required to be filed, the exemptions
from the requirements of the IDE
regulations for preamendments class III
devices in § 812.2(c)(1) and (c)(2) will

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cease to apply to any device that is: (1)
Not legally on the market on or before
that date or (2) legally on the market on
or before that date but for which a PMA
is not filed by that date, or for which
PMA approval has been denied or
withdrawn.
If a PMA for a class III device is not
filed with FDA within 90 days after the
date of issuance of any final order
requiring premarket approval for the
device, the device would be deemed
adulterated under section 501(f) of the
FD&C Act. The device may be
distributed for investigational use only
if the requirements of the IDE
regulations are met. The requirements
for significant risk devices include
submitting an IDE application to FDA
for review and approval. An approved
IDE is required to be in effect before an
investigation of the device may be
initiated or continued under § 812.30.
FDA, therefore, recommends that IDE
applications be submitted to FDA at
least 30 days before the end of the 90day period after the issuance of the final
order to avoid interrupting any ongoing
investigations.
Because ECP devices intended for the
treatment of chronic stable angina that
is refractory to optimal anti-Anginal
medical therapy and without options for
revascularization can currently be
marketed after receiving clearance of an
application for premarket notification,
and FDA is proposing to reclassify these
devices as class II requiring clearance of
an application for premarket
notification, this order, if finalized, will
not require a new premarket submission
for ECP devices intended for the
treatment of chronic stable angina that
is refractory to optimal anti-anginal
medical therapy and without options for
revascularization.
X. Proposed Findings With Respect to
Risks and Benefits
As required by section 515(b) of the
FD&C Act, FDA is publishing its
proposed findings regarding: (1) The
degree of risk of illness or injury
designed to be eliminated or reduced by
requiring that this device have an
approved PMA for Certain Specified
Intended Uses and (2) the benefits to the
public from the use of ECP devices for
Certain Specified Intended Uses.
These findings are based on the
reports and recommendations of the
advisory committees (panels) for the
classification of these devices along
with information submitted in response
to the 515(i) order (74 FR 16214, April
9, 2009) and any additional information
that FDA has obtained. Additional
information regarding the risks as well
as classification associated with this

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device type can be found in 44 FR
13426, 45 FR 7966, and 52 FR 17732 at
17737.
XI. Device Subject to the Proposal to
Require a PMA—External CounterPulsating Devices for Uses Other Than
Treatment of Chronic Stable Angina
That Is Refractory to Optimal AntiAnginal Medical Therapy and Without
Options for Revascularization
(§ 870.5225(c))

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A. Identification
An external counter-pulsating device
is a noninvasive, prescription device
used to assist the heart by applying
positive or negative pressure to one or
more of the body’s limbs in synchrony
with the heart cycle.
B. Summary of Data
For uses other than treatment of
chronic stable angina that is refractory
to optimal anti-anginal medical therapy
and without options for
revascularization as specified in section
IX, FDA concludes that the safety and
effectiveness of these devices have not
been established by adequate scientific
evidence. There is limited scientific
evidence regarding the effectiveness of
ECP devices for uses other than
treatment of chronic stable angina that
is refractory to optimal anti-anginal
medical therapy and without options for
revascularization. Review of the
published scientific literature revealed a
lack of valid scientific evidence to
support indications other than treatment
of chronic stable angina that is
refractory to optimal anti-anginal
medical therapy and without options for
revascularization. There were few
studies that discussed other uses and
those studies did not provide evidence
of reasonable assurance of effectiveness
due to lack of relevant details regarding
study design, conduct and results, use
of flawed study designs, and publication
bias (Refs. 6 to 11). FDA presented the
findings of our literature search for ECP
devices for uses other than treatment of
chronic stable angina that is refractory
to optimal anti-anginal medical therapy
and without options for
revascularization to the Circulatory
System Devices Panel (the Panel) on
December 5, 2012. Based on FDA’s
findings, the Panel concluded that
available scientific evidence is not
adequate to support the effectiveness of
ECP devices for uses other than
treatment of chronic stable angina that
is refractory to optimal anti-anginal
medical therapy and without options for
revascularization. The Panel also
recommended that ECP devices for
Certain Specified Intended Uses should

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remain in class III (subject to premarket
approval application). Although the
Panel noted that ECP devices are not
life-supporting, the devices present a
potential unreasonable risk of injury
given that risks to health exist that are
not balanced by a benefit that has been
established through adequate scientific
evidence to demonstrate safety and
effectiveness.
The Panel transcript and other
meeting materials are available on
FDA’s Web site (Ref. 5).
C. Risks to Health
The risks to health for ECP devices for
uses other than treatment of chronic
stable angina that is refractory to
optimal anti-anginal medical therapy
and without options for
revascularization are the same as
outlined in section V.
D. Benefits of ECP Devices
As discussed previously, there is
limited scientific evidence regarding the
effectiveness of ECP devices for uses
other than treatment of chronic stable
angina that is refractory to optimal antianginal medical therapy and without
options for revascularization. Because
the benefits of these devices for such
uses are unknown, it is impossible to
estimate the direct effect of the devices
on patient outcomes. However, claims
for the devices state that the devices
have the potential to benefit the public
by augmenting cardiac output,
increasing coronary blood flow, and
stimulating circulation in the lower
extremities.
XII. PMA Requirements
A PMA for ECP devices for Certain
Specified Intended Uses must include
the information required by section
515(c)(1) of the FD&C Act. Such a PMA
should also include a detailed
discussion of the risks identified
previously, as well as a discussion of
the effectiveness of the device for which
premarket approval is sought. In
addition, a PMA must include all data
and information on: (1) Any risks
known, or that should be reasonably
known, to the applicant that have not
been identified in this document; (2) the
effectiveness of the device that is the
subject of the application; and (3) full
reports of all preclinical and clinical
information from investigations on the
safety and effectiveness of the device for
which premarket approval is sought.
A PMA must include valid scientific
evidence to demonstrate reasonable
assurance of the safety and effectiveness
of the device for its intended use (see
§ 860.7(c)(1)). Valid scientific evidence
is ‘‘evidence from well-controlled

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investigations, partially controlled
studies, studies and objective trials
without matched controls, welldocumented case histories conducted by
qualified experts, and reports of
significant human experience with a
marketed device, from which it can
fairly and responsibly be concluded by
qualified experts that there is reasonable
assurance of the safety and effectiveness
of a device under its conditions of use
* * * Isolated case reports, random
experience, reports lacking sufficient
details to permit scientific evaluation,
and unsubstantiated opinions are not
regarded as valid scientific evidence to
show safety or effectiveness.’’ (See
§ 860.7(c)(2).)
XIII. Opportunity To Request a Change
in Classification
Before requiring the filing of a PMA
for a device, FDA is required by section
515(b)(2)(D) of the FD&C Act to provide
an opportunity for interested persons to
request a change in the classification of
the device based on new information
relevant to the classification. Any
proceeding to reclassify the device will
be under the authority of section 513(e)
of the FD&C Act.
A request for a change in the
classification of ECP devices for Certain
Specified Intended Uses is to be in the
form of a reclassification petition
containing the information required by
§ 860.123, including new information
relevant to the classification of the
device.
XIV. Codification of Orders
Prior to the amendments by FDASIA,
section 513(e) of the FD&C Act provided
for FDA to issue regulations to reclassify
devices and section 515(b) of the FD&C
Act provided for FDA to issue
regulations to require approval of an
application for premarket approval for
preamendments devices or devices
found to be substantially equivalent to
preamendments devices. Because
sections 513(e) and 515(b) as amended
require FDA to issue final orders rather
than regulations, FDA will continue to
codify reclassifications and
requirements for approval of an
application for premarket approval,
resulting from changes issued in final
orders, in the Code of Federal
Regulations. Therefore, under section
513(e)(1)(A)(i) of the FD&C Act, as
amended by FDASIA, in this proposed
order, we are proposing to revoke the
requirements in § 870.5225 related to
the classification of external counterpulsating devices for chronic stable
angina that is refractory to optimal antianginal medical therapy and without
options for revascularization as class III

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devices and to codify the
reclassification of external counterpulsating devices for chronic stable
angina that is refractory to optimal antianginal medical therapy and without
options for revascularization into class
II.

docket number found in the brackets in
the heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at http://
www.regulations.gov.

XV. Environmental Impact
The Agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.

XIX. References

XVI. Paperwork Reduction Act of 1995
This proposed order refers to
collections of information that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520).
The collections of information in 21
CFR part 814 have been approved under
OMB control number 0910–0231. The
collections of information in part 807,
subpart E, have been approved under
OMB control number 0910–0120.
The effect of this order, if finalized, is
to shift certain devices from the 510(k)
premarket notification process to the
PMA process. FDA estimates that there
will be two fewer 510(k) submissions as
a result of this order, if finalized. Based
on FDA’s most recent estimates, this
will result in a 91-hour burden decrease
to OMB control number 0910–0120,
which is the control number for the
510(k) premarket notification process.
However, because FDA does not expect
to receive any new PMAs as a result of
this order, we estimate no burden
increase to OMB control number 0910–
0231 based on this order, if finalized.
Therefore, on net, FDA expects a burden
hour decrease of 91 due to this proposed
regulatory change.
The collections of information in part
812 have been approved under OMB
control number 0910–0078.

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XVII. Proposed Effective Date
FDA is proposing that any final order
based on this proposed order become
effective 90 days after date of
publication of the final order in the
Federal Register.
XVIII. Comments
Interested persons may submit either
electronic comments regarding this
document to http://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to submit one set of
comments. Identify comments with the

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The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at http://
www.regulations.gov. (FDA has verified
the Web site address in this reference
section, but FDA is not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register.)
1. Arora, R. R., T. M. Chou, D. Jain, et al.,
‘‘The Multicenter Study of Enhanced
External Counterpulsation (MUST–
EECP): Effect of EECP on ExerciseInduced Myocardial Ischemia and
Anginal Episodes,’’ Journal of the
American College of Cardiology, vol. 33,
pp. 1833–1840, 1999.
2. Arora, R. R., T. M. Chou, D. Jain, et al.,
‘‘Effects of Enhanced External
Counterpulsation on Health-Related
Quality of Life Continue 12 Months After
Treatment: A Substudy of the
Multicenter Study of Enhanced External
Counterpulsation,’’ Journal of
Investigative Medicine, vol. 50, pp. 25–
32, 2002.
3. Gloekler, S., P. Meier, S. F. de Marchi, et
al., ‘‘Coronary Collateral Growth by
External Counterpulsation: A
Randomised Controlled Trial,’’ Heart,
vol. 96, pp. 202–207, 2010.
4. Casey, D. P., D. T. Beck, W. W. Nichols,
et al., ‘‘Effects of Enhanced External
Counterpulsation on Arterial Stiffness
and Myocardial Oxygen Demand in
Patients With Chronic Angina Pectoris,’’
American Journal of Cardiology, vol.
107, pp. 1466–1472, 2011.
5. FDA, the Panel transcript and other
meeting materials, (http://www.fda.gov/
AdvisoryCommittees/Committees
MeetingMaterials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/
CirculatorySystemDevicesPanel/
ucm300073.htm).
6. Abbottsmith, C. W., E. S. Chung, T.
Varricchione, et al., ‘‘Enhanced External
Counterpulsation Improves Exercise
Duration and Peak Oxygen Consumption
in Older Patients With Heart Failure: A
Subgroup Analysis of the PEECH Trial,’’
Congestive Heart Failure, vol. 12, pp.
307–311, 2006.
7. Feldman, A. M., M. A. Silver, G. S.
Francis, et al., ‘‘Enhanced External
Counterpulsation Improves Exercise
Tolerance in Patients With Chronic Heart
Failure,’’ Journal of the American
College of Cardiology, vol. 48, pp. 1198–
1205, 2006.

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8. Kozdag, G., G. Ertas, F. Aygun, et al.,
‘‘Clinical Effects of Enhanced External
Counterpulsation Treatment in Patients
With Ischemic Heart Failure,’’ Anadolu
Kardiyol Derg, vol. 12, pp. 214–221,
2012.
9. Triulzi, E., S. Devizzi, G. Rovelli, et al.,
[‘‘Efficacy of Enhanced Aortic Diastolic
Pressure With An External
Counterpulsation Method in the Acute
Myocardial Infarction’’ (author’s
translation)], Giornale Italiano di
Cardiologia, vol. 10, pp. 690–702, 1980.
10. Vijayaraghavan, K., L. Santora, J. Kahn, et
al., ‘‘New Graduated Pressure Regimen
for External Counterpulsation Reduces
Mortality and Improves Outcomes in
Congestive Heart Failure: A Report From
the Cardiomedics External
Counterpulsation Patient Registry,’’
Congestive Heart Failure, vol. 11, pp.
147–152, 2005.
11. Amsterdam, E. Z., J. Banas, J. M. Criley,
et al., ‘‘Clinical Assessment of External
Pressure Circulatory Assistance in Acute
Myocardial Infarction,’’ American
Journal of Cardiology, vol. 45, pp. 349–
356, 1980.

List of Subjects in 21 CFR Part 870
Medical devices, Cardiovascular
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 870 be amended as follows:
PART 870—CARDIOVASCULAR
DEVICES
1. The authority citation for 21 CFR
part 870 continues to read as follows:

■

Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.

2. Revise § 870.5225 to read as
follows:

■

§ 870.5225
device.

External counter-pulsating

(a) Identification. An external
counter-pulsating device is a
noninvasive, prescription device used to
assist the heart by applying positive or
negative pressure to one or more of the
body’s limbs in synchrony with the
heart cycle.
(b) Classification. (1) Class II (special
controls) when the device is intended
for the treatment of chronic stable
angina that is refractory to optimal antianginal medical therapy and without
options for revascularization. The
special controls for this device are:
(i) Nonclinical performance
evaluation of the device must
demonstrate a reasonable assurance of
safety and effectiveness for applied
pressure, synchronization of therapy
with the appropriate phase of the
cardiac cycle, and functionality of

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alarms during a device malfunction or
an abnormal patient condition;
(ii) Reliabilities of the mechanical and
electrical systems must be established
through bench testing under simulated
use conditions and matched by
appropriate maintenance schedules;
(iii) Software design and verification
and validation must be appropriately
documented;
(iv) The skin-contacting components
of the device must be demonstrated to
be biocompatible;
(v) Appropriate analysis and testing
must be conducted to verify electrical
safety and electromagnetic compatibility
of the device; and
(vi) Labeling must bear all
information required for the safe and
effective use of the device, including a
detailed summary of the device-related
and procedure-related complications
pertinent to use of the device.
(2) Class III (premarket approval) for
the following intended uses: Unstable
angina pectoris; acute myocardial
infarction; cardiogenic shock;
congestive heart failure; postoperative
treatment of patients who have
undergone coronary artery bypass
surgery; peripheral arterial disease
associated with ischemic ulcers rest
pain or claudication, threatened
gangrene, insufficient blood supply at
an amputation site, persisting ischemia
after embolectomy or bypass surgery,
and/or pre- and post-arterial
reconstruction to improve runoff;
diabetes complicated by peripheral
arterial disease or other conditions
possibly related to arterial insufficiency
including nocturnal leg cramps and/or
necrobiosis diabeticorum; venous
diseases, including prophylaxis of deep
vein thrombophlebitis, edema (e.g.,
chronic lymphedema) and/or induration
(e.g., stasis dermatitis) associated with
chronic venous stasis, venous stasis
ulcers, and/or thrombophlebitis; athletic
injuries, including Charley horses,
pulled muscles and/or edematous
muscles; necrotizing cellulitis.
(c) Date premarket approval
application (PMA) or notice of
completion of product development
protocol (PDP) is required. A PMA or
notice of completion of a PDP is
required to be filed with FDA on or
before [A DATE WILL BE ADDED THAT
WILL BE 90 DAYS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL
ORDER IN THE FEDERAL
REGISTER], for any external counterpulsating device, with an intended use
described in (b)(2) of this section, that
was in commercial distribution before
May 28, 1976, or that has, on or before
[A DATE WILL BE ADDED THAT WILL
BE 90 DAYS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL

VerDate Mar<15>2010

17:56 May 20, 2013

Jkt 229001

ORDER IN THE FEDERAL
REGISTER], been found to be
substantially equivalent to any external
counter-pulsating device, with an
intended use described in (b)(2) of this
section, that was in commercial
distribution before May 28, 1976. Any
other external counter-pulsating device
with an intended use described in (b)(2)
of this section shall have an approved
PMA or declared completed PDP in
effect before being placed in commercial
distribution.
Dated: May 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–12122 Filed 5–20–13; 8:45 am]
BILLING CODE 4160–01–P

To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
If
you have questions on this proposed
rule, call or email Petty Officer Joseph
McCollum, U.S. Coast Guard Sector
Lake Michigan; telephone 414–747–
7148, email
[email protected]. If you
have questions on viewing or submitting
material to the docket, call Barbara
Hairston, Program Manager, Docket
Operations, telephone (202) 366–9826.

FOR FURTHER INFORMATION CONTACT:

SUPPLEMENTARY INFORMATION:

DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
RIN 1625–AA00

Safety Zone; Chicago Harbor, Navy
Pier Southeast, Chicago, IL
AGENCY: Coast Guard, DHS.
ACTION: Notice of proposed rulemaking.
SUMMARY: The Coast Guard proposes to
amend the Safety Zone for Chicago
Harbor, Navy Pier Southeast, Chicago,
IL. This Zone is intended to restrict
vessels from a portion of Chicago Harbor
during fireworks displays, races, and
other marine events that occur
throughout each calendar year. The
safety zone established by this proposed
rule is necessary to protect spectators,
participants, and vessels from the
hazards associated with these fireworks
displays, boat races, and other events.
DATES: Comments and related materials
must be received by the Coast Guard on
or before June 20, 2013.
ADDRESSES: You may submit comments
identified by docket number USCG–
2013–0320 using any one of the
following methods:
(1) Federal eRulemaking Portal:
http://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue SE., Washington, DC 20590–
0001.
(4) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.

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DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
CFR Code of Federal Regulations

A. Public Participation and Request for
Comments

[Docket No. USCG–2013–0320]

PO 00000

Table of Acronyms

We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted
without change to http://
www.regulations.gov and will include
any personal information you have
provided.
1. Submitting Comments
If you submit a comment, please
include the docket number for this
rulemaking, indicate the specific section
of this document to which each
comment applies, and provide a reason
for each suggestion or recommendation.
You may submit your comments and
material online at http://
www.regulations.gov, or by fax, mail, or
hand delivery, but please use only one
of these means. If you submit a
comment online, it will be considered
received by the Coast Guard when you
successfully transmit the comment. If
you fax, hand deliver, or mail your
comment, it will be considered as
having been received by the Coast
Guard when it is received at the Docket
Management Facility. We recommend
that you include your name and a
mailing address, an email address, or a
telephone number in the body of your
document so that we can contact you if
we have questions regarding your
submission.
To submit your comment online, go to
http://www.regulations.gov, type the
docket number (USCG–2012–0320) in
the ‘‘SEARCH’’ box and click

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