Document ID: FDA-2013-N-0487-0004
Agency: fda
Document Type: Rule
Title: Cardiovascular Devices; Reclassification of External Counter-
Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date
of Requirement for Premarket Approval for External Counter-
Pulsating Devices for Other Specified Intended Uses
Posted Date: 2013-12-30T05:00Z

[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Rules and Regulations]
[Pages 79304-79308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31216]

[[Page 79304]]

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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 Counter-
Pulsating Devices for Treatment of Chronic Stable Angina; Effective 
Date of Requirement for Premarket Approval for External Counter-
Pulsating Devices for Other Specified Intended Uses

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
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), and 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.

DATES: This order is effective December 30, 2013.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993, 301-796-6380, 
angela.krueger@fda.hhs.gov.

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 
(Pub. L. 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) (Public Law 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(d) 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 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. Section 515(b)(1) 
of the FD&C Act directs FDA to issue an order requiring premarket 
approval for a preamendments class III device.
    Although, under the FD&C Act, the manufacturer of a 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 this 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 
mechanism 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 reclassifying ECP devices for treatment of chronic stable 
angina that is refractory to optimal anti-anginal 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 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 Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., 
General Medical

[[Page 79305]]

Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers 
Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 
U.S. 1062 (1986).)
    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 reclassifying a device. 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 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 on December 5, 2012. The 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. The 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 panel further agreed that the special 
controls identified by FDA were appropriate to mitigate the relevant 
risks to health for this use. FDA published a proposed order in the 
Federal Register of May 21, 2013 (78 FR 29672). FDA received and has 
considered one comment on this proposed order as discussed in section 
II of this document. Therefore, FDA has met the requirements under 
section 513(e)(1) of the FD&C Act.

B. Requirement for Premarket Approval Application

    FDA is requiring PMAs for ECP devices for Certain Specified 
Intended Uses. For the purposes of this final 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.
    Section 515(b)(1) of the FD&C Act sets forth the process for 
issuing a final order requiring PMAs. 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. As discussed 
in this document, FDA has met the requirements under section 515(b)(1) 
of the FD&C Act.
    FDA 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 on December 5, 2012. The panel recommended that ECP 
devices for Certain Specified Intended Uses remain in class III. The 
panel supported FDA's conclusion that 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 published a proposed order in the Federal Register of May 21, 
2013 (78 FR 29672), that satisfied the requirements of section 
515(b)(2) of the FD&C Act, which 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 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. FDA received and has considered one comment on this proposed 
order as discussed in section II of this document.
    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 final 
order, the later of these two time periods is the 90-day period. Since 
these devices were classified in 1980, the 30-month period

[[Page 79306]]

has expired (45 FR 7966; February 5, 1980). Therefore, 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 this final order. If a 
PMA is not filed for such device within 90 days after the issuance of 
this final order, the device will 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 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). FDA requests that manufacturers take action to prevent the 
further use of devices for which no PMA has been filed.

II. Public Comments in Response to the Proposed Order

    In response to the May 21, 2013, proposed order to reclassify ECP 
devices for treatment of chronic stable angina that is refractory to 
optimal anti-anginal medical therapy and without options for 
revascularization, and require the filing of a PMA or a notice of 
completion of a PDP for ECP devices for Certain Specified Intended 
Uses, FDA received one comment. The comment supported FDA's intent to 
call for PMAs for ECP devices for Certain Specified Intended Uses, but 
disagreed with FDA's intent to reclassify ECP devices intended for 
treatment of chronic stable angina that is refractory to optimal anti-
anginal medical therapy and without options for revascularization, 
stating, ``Since the law specifies that high-risk devices are 
considered class III, we see no justification for down-classifying this 
obviously high-risk device used for the high-risk indication of chronic 
stable angina, and all other indications. We believe that high-risk 
cardiac devices should remain class III devices and be subjected to PMA 
because they are life-supporting and life-sustaining.'' The commenter 
further notes that ``Currently available clinical evidence does not 
prove safety and effectiveness for these devices for any indication,'' 
and that, ``Special controls are not enough to ensure safety and 
effectiveness.'' FDA disagrees with this comment. According to section 
513(a)(1)(C) of the FD&C Act, a class III device is defined as a device 
which (1) ``cannot be classified as a class I device because 
insufficient information exists to determine that the application of 
general controls are sufficient to provide reasonable assurance of the 
safety and effectiveness of the device,'' and (2) ``cannot be 
classified as a class II device because insufficient information exists 
to determine that the special controls . . . would provide reasonable 
assurance of its safety and effectiveness,'' and (3) ``is purported or 
represented to be for a use in supporting or sustaining human life or 
for a use which is of substantial importance in preventing impairment 
of human health,'' or (4) ``presents a potential unreasonable risk of 
illness or injury.'' FDA does not believe that ECP devices are 
considered life-supporting devices, a viewpoint which was supported by 
the panel members at the December 5, 2012, device classification panel 
meeting (the 2012 Panel). In addition, FDA believes that the available 
evidence supports a reasonable assurance of safety and effectiveness, 
that special controls, in addition to general controls, would be 
sufficient to provide such assurance, and there is not an unreasonable 
risk of illness or injury for ECP devices intended for treatment of 
chronic stable angina that is refractory to optimal anti-anginal 
medical therapy and without options for revascularization. The 2012 
Panel agreed with FDA's conclusions and further agreed that the special 
controls identified by FDA were appropriate to mitigate the relevant 
risks to health. Therefore, FDA disagrees 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 classified as class III devices. FDA believes that the 
identified special controls mitigate the risks to health and provide a 
reasonable assurance of safety and effectiveness for this patient 
population.
    The commenter further notes that ``having two different 
classifications for the same device, based on different indications, 
does not provide adequate safeguards for patients, or sufficient 
evidence-based guidelines for physicians. Instead, it provides an 
incentive for companies to use the easier approval pathway, the 510(k) 
process rather than the PMA pathway, knowing that physicians can use 
the implant off label for any indication that they choose.'' FDA 
disagrees with this comment. FDA does not regulate the practice of 
medicine but rather regulates the use of a device as indicated by the 
party offering the device for interstate commerce. The indications for 
ECP devices are limited by the codified classification. Also, ECP 
devices are not implants as referred to by the commenter.

III. The Final Order

    Under sections 513(e) and 515(b) of the FD&C Act, FDA is adopting 
its findings as published in the preamble to the proposed order (78 FR 
29672). FDA is issuing this final order to require the filing of a PMA 
or a notice of completion of a PDP for ECP devices intended for Certain 
Specified Intended Uses (see section I.B of this document):
    In addition, FDA is issuing this final order to reclassify ECP 
devices for treatment of chronic stable angina that is refractory to 
optimal anti-anginal medical therapy and without options for 
revascularization from class III to class II and establish special 
controls. This final order will revise 21 CFR part 870.
    Under the final order, a PMA or a notice of completion of a PDP is 
required to be filed on or before 90 days after the date of publication 
of the final order in the Federal Register, for any of these class III 
preamendments devices that were in commercial distribution before May 
28, 1976, or that has been found by FDA to be substantially equivalent 
to such a device on or before 90 days after the date of publication of 
the final order in the Federal Register. An approved PMA or a declared 
completed PDP is required to be in effect for any such devices on or 
before 180 days after FDA files the application. Any other class III 
preamendments device subject to this order that was not in commercial 
distribution before May 28, 1976, is required to have an approved PMA 
or a declared completed PDP in effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for any of the class 
III preamendments devices is not filed on or before the 90th day past 
the effective

[[Page 79307]]

date of this regulation, that device will be deemed adulterated under 
section 501(f)(1)(A) of the FD&C Act, and commercial distribution of 
the device must cease immediately. The device may, however, be 
distributed for investigational use, if the requirements of the IDE 
regulations (part 812) are met.
    Following the effective date of this final order, firms submitting 
a 510(k) premarket notification for a ECP device intended for treatment 
of chronic stable angina that is refractory to optimal anti-anginal 
medical therapy and without options for revascularization will need 
either to: (1) Comply with the particular mitigation measures set forth 
in the codified special controls or (2) use alternative mitigation 
measures, but demonstrate to the Agency's satisfaction that those 
alternative measures identified by the firm will provide at least an 
equivalent assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the devices. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of 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, and therefore, this device type is not 
exempt from premarket notification requirements.
    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 part 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.

IV. 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.

V. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subpart B, 
have been approved under OMB control number 0910-0231; and the 
collections of information under 21 CFR part 801 have been approved 
under OMB control number 0910-0485.

VI. 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. Although sections 513(e) and 515(b) as amended 
require FDA to issue final orders rather than regulations, FDASIA also 
provides for FDA to revoke previously issued regulations by order. FDA 
will continue to codify reclassifications and requirements for approval 
of an application for premarket approval 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 final order, we are revoking the 
requirements in Sec.  870.5225 related to the classification of 
external counter-pulsating devices for chronic stable angina that is 
refractory to optimal anti-anginal medical therapy and without options 
for revascularization as class III devices and codifying the 
reclassification of these devices into class II.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
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.

0
2. Revise Sec.  870.5225 to read as follows:

Sec.  870.5225  External counter-pulsating device.

    (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 anti-anginal 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 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 include 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

[[Page 79308]]

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 March 31, 2014, for any external counter-pulsating device, with 
an intended use described in paragraph (b)(2) of this section, that was 
in commercial distribution before May 28, 1976, or that has, on or 
before March 31, 2014, been found to be substantially equivalent to any 
external counter-pulsating device, with an intended use described in 
paragraph (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 paragraph (b)(2) of this section shall 
have an approved PMA or declared completed PDP in effect before being 
placed in commercial distribution.

    Dated: December 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-31216 Filed 12-27-13; 8:45 am]
BILLING CODE 4160-01-P