Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation, 79300-79303 [2013-31218]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Rules and Regulations]
[Pages 79300-79303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31218]



[[Page 79300]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2013-N-0581]


Cardiovascular Devices; Reclassification of Intra-Aortic Balloon 
and Control Systems for Acute Coronary Syndrome, Cardiac and Non-
Cardiac Surgery, or Complications of Heart Failure; Effective Date of 
Requirement for Premarket Approval for Intra-Aortic Balloon and Control 
Systems for Septic Shock or Pulsatile Flow Generation

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 intra-aortic balloon and control system (IABP) 
devices when indicated for acute coronary syndrome, cardiac and non-
cardiac surgery, or complications of heart failure, 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 IABPs when 
indicated for septic shock or pulsatile flow generation.

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) (Pub. L. 112-144), establish 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 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 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 
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 amended section 515(b) of the FD&C Act 
changing the mechanism for requiring premarket approval for a 
preamendments class III device from rulemaking to an administrative 
order.

A. Reclassification

    FDA is reclassifying IABP devices when indicated for acute coronary 
syndrome, cardiac and non-cardiac surgery, or complications of heart 
failure 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) of the 
FD&C Act must be ``valid scientific evidence,'' as defined in section 
513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General 
Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir.

[[Page 79301]]

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. 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 IABP devices on December 5, 2012 (the 2012 Panel). 
The 2012 Panel recommended that IABP devices indicated for acute 
coronary syndrome, cardiac and non-cardiac surgery, or complications of 
heart failure be reclassified to class II with special controls. The 
2012 Panel agreed with FDA's conclusion that the available scientific 
evidence is adequate to support the safety and effectiveness of IABP 
devices indicated for acute coronary syndrome, cardiac and non-cardiac 
surgery, or complications of heart failure. The 2012 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 June 19, 2013 (78 FR 36702) 
(the 2013 proposed order). FDA received and has considered one comment 
on the 2013 proposed order as discussed in section II of this document. 
Therefore, FDA has met this requirement under section 513(e)(1) of the 
FD&C Act.

B. Requirement for Premarket Approval Application

    FDA is requiring PMAs for IABP devices when indicated for septic 
shock or pulsatile flow generation.
    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, payers, 
and providers. FDA held a meeting of a device classification panel 
described in section 513(b) of the FD&C Act with respect to IABP 
devices on December 5, 2012. The 2012 Panel recommended that IABP 
devices when indicated for septic shock or pulsatile flow generation 
remain in class III (subject to premarket approval application). The 
2012 Panel supported FDA's conclusion that the effectiveness of IABP 
devices when indicated for septic shock or pulsatile flow generation 
has not been established through adequate scientific evidence. FDA 
published the 2013 proposed order on June 19, 2013 (78 FR 36702). FDA 
received and has considered one comment on the 2013 proposed order as 
discussed in section II of this document, 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) 
the 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. The 2013 proposed order satisfies these requirements.
    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 IABP 
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 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

[[Page 79302]]

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 2013 proposed order to reclassify IABP devices 
when indicated for acute coronary syndrome, cardiac and non-cardiac 
surgery, or complications of heart failure, and require the filing of a 
PMA or a notice of completion of a PDP for IABP devices when indicated 
for septic shock or pulsatile flow generation, FDA received one 
comment. The comment supported FDA's intent to call for PMAs for IABP 
devices when indicated for septic shock or pulsatile flow generation, 
but disagreed with FDA's intent to reclassify IABP devices when 
indicated for acute coronary syndrome, cardiac and non-cardiac surgery, 
or complications of heart failure, stating that the risks to health are 
``serious,'' and ``special controls are inadequate to provide 
reasonable assurance of safety and effectiveness for these complex, 
life-supporting devices.''
    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.'' Although FDA considers IABP devices to be life-supporting, a 
viewpoint which was supported by the 2012 Panel, FDA believes that, 
based on the available evidence, that special controls, in addition to 
general controls, would be sufficient to provide a reasonable assurance 
of safety and effectiveness, and there is not an unreasonable risk of 
illness or injury for IABP devices when indicated for acute coronary 
syndrome, cardiac and non-cardiac surgery, or complications of heart 
failure. The 2012 Panel agreed with FDA's conclusions and provided the 
following rationale for recommending that these devices be reclassified 
to class II: (1) There is a wealth of clinical experience that attests 
to the benefit of the device; (2) there is an important advantage to 
use of intra-aortic balloon counter-pulsation to provide hemodynamic 
stability or protection from ischemia in precarious or unstable 
patients; and (3) the recommended special controls will mitigate the 
health risks associated with the device. Therefore, FDA disagrees that 
IABP devices when indicated for acute coronary syndrome, cardiac and 
non-cardiac surgery, or complications of heart failure 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 with 
high morbidity and mortality.
    The commenter also provided a summary of recalls and adverse event 
reports in FDA's Manufacturer and User Facility Device Experience 
(MAUDE) database for this device type to support their perspective that 
reclassification is inappropriate for IABP devices when indicated for 
acute coronary syndrome, cardiac and non-cardiac surgery, or 
complications of heart failure. FDA is aware of this data, fully 
considered this information prior to the proposed reclassification, and 
presented this information to the 2012 Panel. As such, this is not new 
information which would have a bearing on FDA's decision to reclassify 
IABP devices when indicated for acute coronary syndrome, cardiac and 
non-cardiac surgery, or complications of heart failure from class III 
to class II.
    The commenter further notes that ``A major problem with this 
proposed order is that it splits the device into two classifications 
(Class III and Class II) . . . down-classification for any indication 
would create an enormous and dangerous loophole that would allow 
manufacturers to avoid the more rigorous PMA review process.'' 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 
IABP devices are limited by the codified classification.
    The commenter also states that ``the down-classification of these 
devices means that companies manufacturing new models with unique 
characteristics in the future would not be required to provide that 
their products are safe or effective.'' The commenter suggests that 
classification to class II (special controls) precludes FDA from 
requesting clinical data for these devices. FDA disagrees with this 
comment. FDA believes that the proposed special controls provide a 
reasonable assurance of safety and effectiveness for IABP devices that 
feature similar technology when indicated for acute coronary syndrome, 
cardiac and non-cardiac surgery, or complications of heart failure. FDA 
is also not precluded from requesting clinical data for IABP devices 
where it is necessary to demonstrate substantial equivalence.

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 2013 proposed order. 
FDA is issuing this final order to require the filing of a PMA or a 
notice of completion of a PDP for IABP devices when indicated for 
septic shock or pulsatile flow generation. In addition, FDA is issuing 
this final order to reclassify IABP devices when indicated for acute 
coronary syndrome, cardiac and non-cardiac surgery, or complications of 
heart failure from class III to class II and establish special 
controls. This final order will revise part 870 (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 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 an IABP device when indicated for 
acute coronary syndrome, cardiac and non-cardiac surgery, or 
complications of

[[Page 79303]]

heart failure 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 IABP devices when indicated for acute coronary 
syndrome, cardiac and non-cardiac surgery, or complications of heart 
failure, 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 septic shock or pulsatile flow generation, may remove such intended 
uses from the device's labeling by initiating a correction within 90 
days after issuance of this final order. Under 21 CFR 806.10(a)(2) a 
device manufacturer or importer initiating a correction to remedy a 
violation of the FD&C Act that may present a risk to health is required 
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) of the FD&C 
Act 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.  870.3535 related to 
the classification of IABP devices when indicated for acute coronary 
syndrome, cardiac and non-cardiac surgery, or complications of heart 
failure as class III devices and codifying the reclassification of 
these devices into class II.

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, 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.  870.3535 to read as follows:


Sec.  870.3535  Intra-aortic balloon and control system.

    (a) Identification. An intra-aortic balloon and control system is a 
prescription device that consists of an inflatable balloon, which is 
placed in the aorta to improve cardiovascular functioning during 
certain life-threatening emergencies, and a control system for 
regulating the inflation and deflation of the balloon. The control 
system, which monitors and is synchronized with the electrocardiogram, 
provides a means for setting the inflation and deflation of the balloon 
with the cardiac cycle.
    (b) Classification. (1) Class II (special controls) when the device 
is indicated for acute coronary syndrome, cardiac and non-cardiac 
surgery, or complications of heart failure. The special controls for 
this device are:
    (i) Appropriate analysis and non-clinical testing must be conducted 
to validate electromagnetic compatibility and electrical safety of the 
device;
    (ii) Software verification, validation, and hazard analysis must be 
performed;
    (iii) The device must be demonstrated to be biocompatible;
    (iv) Sterility and shelf-life testing must demonstrate the 
sterility of patient-contacting components and the shelf life of these 
components;
    (v) Non-clinical performance evaluation of the device must 
demonstrate mechanical integrity, durability, and reliability to 
support its intended purpose; and
    (vi) Labeling must include a detailed summary of the device- and 
procedure-related complications pertinent to use of the device.
    (2) Class III (premarket approval) when the device is indicated for 
septic shock and pulsatile flow generation.
    (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 the Food and 
Drug Administration on or before March 31, 2014, for any intra-aortic 
balloon and control system indicated for septic shock or pulsatile flow 
generation 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 intra-aortic balloon and control system indicated for 
septic shock or pulsatile flow generation that was in commercial 
distribution before May 28, 1976. Any other intra-aortic balloon and 
control system indicated for septic shock or pulsatile flow generation 
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. 2013-31218 Filed 12-27-13; 8:45 am]
BILLING CODE 4160-01-P