Document ID: FDA-2013-N-1518-0001
Agency: fda
Document Type: Proposed Rule
Title: Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and
Circulatory Bypass; Effective Date of Requirement for Premarket Approval
for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary
Ventricular Support
Posted Date: 2014-01-07T05:00Z

[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Proposed Rules]
[Pages 765-773]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00027]

[[Page 765]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2013-N-1518]

Cardiovascular Devices; Reclassification of Nonroller-Type 
Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory 
Bypass; Effective Date of Requirement for Premarket Approval for 
Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary 
Ventricular Support

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed 
administrative order to reclassify nonroller-type cardiopulmonary 
bypass blood pump devices, when used for cardiopulmonary and 
circulatory bypass, a preamendments class III device, into class II 
(special controls) and subject to premarket notification 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 nonroller-type cardiopulmonary bypass 
blood pump devices for temporary ventricular support. The Agency is 
also summarizing its proposed findings regarding the degree of risk of 
illness or injury designed to be eliminated or reduced by requiring the 
devices to meet the statute's approval requirements when used for 
temporary ventricular support. 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.

DATES: Submit either electronic or written comments on this proposed 
order by April 7, 2014. FDA intends that, if a final order based on 
this proposed order is issued, anyone who wishes to continue to market 
nonroller-type cardiopulmonary bypass blood pump devices for temporary 
ventricular support 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 of this document 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-1518, by any of the following methods:

Electronic Submissions

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

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper 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-1518 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 of this document.
    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 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), 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 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 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

[[Page 766]]

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 
nonroller-type cardiopulmonary bypass blood pump devices for 
cardiopulmonary and circulatory bypass 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 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 (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 for 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 has held a meeting of a device classification panel 
described in section 513(b) of the FD&C Act with respect to nonroller-
type cardiopulmonary bypass blood pump devices, and therefore, has met 
this requirement under section 515(e) 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 nonroller-type cardiopulmonary 
bypass blood pump devices for temporary ventricular support.
    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. The meeting of 
the device classification panel described in section 513(b) of the FD&C 
Act with respect to nonroller-type cardiopulmonary bypass blood pump 
devices satisfies 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 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).
    Under section 501(f) of the FD&C Act (21 U.S.C. 351(f)), a 
preamendments class III device may be commercially distributed without 
a PMA until 90 days after FDA issues a final order (or a final rule 
under section 515(b) of the FD&C Act if issued prior to the enactment 
of FDASIA) 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 nonroller-type cardiopulmonary bypass 
blood pump 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 7959, February 5, 1980). Therefore, if 
the proposal to require premarket approval for nonroller-type 
cardiopulmonary bypass blood pump devices for

[[Page 767]]

temporary ventricular support 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 
devices 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 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) of the FD&C Act, interested 
persons are being offered the opportunity to request reclassification 
of nonroller-type cardiopulmonary bypass blood pump devices for 
temporary ventricular support.

II. Device Description

    A nonroller-type blood pump, also referred to as a nonroller-pump 
(NRP), is a prescription device that uses a method other than revolving 
rollers to pump blood. While the technologies utilized by NRPs which 
have been reviewed by the Agency to date include: (1) Centrifugal pumps 
and (2) catheter-based axial pumps, additional methods for blood 
propulsion can be anticipated in future devices.
    To further delineate types of NRP devices and their intended uses, 
FDA proposes to rename the devices in this regulation for purposes of 
consistency and clarity. The term ``NRP Devices for Temporary 
Cardiopulmonary Bypass'' will be used to designate blood pumps that use 
nonroller pump technology temporarily (i.e. <6 hours) to propel blood 
through a cardiopulmonary bypass circuit. The term ``NRP Devices for 
Temporary Circulatory Bypass'' will be used to designate blood pumps 
that utilize nonroller pump technology to provide temporary (i.e. <6 
hours) circulatory bypass around a planned surgical disruption of the 
arterial and venous great vessels (i.e. aorta and vena cavae). The term 
``NRP Devices for Temporary Ventricular Support'' will be used to 
designate blood pumps that use nonroller pump technology (e.g. axial or 
centrifugal flow pumps) to provide temporary (i.e. <6 hours) support of 
ventricular function resulting from ongoing or anticipated episodes of 
immediately reversible myocardial dysfunction.

A. NRP Devices for Temporary Cardiopulmonary and Circulatory Bypass

    NRP devices in current use for temporary cardiopulmonary and 
circulatory bypass rely primarily upon centrifugal pump technology that 
utilizes a rotor to impart energy to the blood in an extracorporeal 
circuit through centrifugal forces. These pumps house an impeller, 
magnet, and housing bottom that fit into a drive unit. The motor drive 
unit holds the disposable blood pump and drives the rotor inside the 
blood pump with a magnet. These types of pumps have been used as part 
of an extracorporeal circuit, external to the body and in combination 
with an oxygenator, to provide cardiopulmonary support for periods 
lasting less than 6 hours. Additionally, centrifugal pumps can be used 
in isolation, external to the body but without an oxygenator, to 
provide temporary circulatory bypass around a planned disruption of the 
circulatory pathway necessary for open surgical procedures on the aorta 
or vena cava. Although all currently available devices rely on 
centrifugal forces to propel blood through these circuits, additional 
methods for blood propulsion can be anticipated in future devices. For 
all these future devices, the technology to propel blood as or more 
efficiently (i.e. adequate volume and with minimal trauma) compared 
with current technology will be essential in the evaluation for 
marketing authorization.

B. NRP Devices for Temporary Ventricular Support

    NRP devices that pump blood for the purpose of full or partial 
temporary (i.e. <6 hours) ventricular support may be divided into two 
broad categories: (1) Those where the temporary NRP device resides 
within the circulation, and 2) those where the temporary NRP device 
resides outside the circulation. NRP devices used for temporary 
ventricular support also typically require percutaneous placement of 
either catheters (which contain the pump device), or access cannulae. 
Either or both of these may be required to reside in and/or traverse 
one or more elements of the circulation (great vessels, valves, septa). 
Examples include catheter-based microaxial-type pumps comprising a pump 
motor, cannula, and catheter that connect to a console. Catheter-based 
microaxial-type pumps are not currently designed to be used with an 
oxygenator but are temporarily implanted within the heart or 
vasculature to provide cardiac support by supplementing the function of 
one or both ventricles, restoring forward flow, and/or allowing the 
ventricle to rest and repair by decreasing the work and energy demands 
secondary to ventricular unloading. Centrifugal pump circuits, where 
the NRP resides outside of the body, have also been used for this 
purpose following percutaneous placement of inflow and outflow cannulas 
into the appropriate chambers and vessels. Future development of other 
pump and cannula technologies to be used for the purpose of temporary 
ventricular support is anticipated.

III. Regulatory History of the Device

    As discussed in the preamble to the proposed rule to classify these 
devices into class III (44 FR 13409, March 9, 1979), the Cardiovascular 
Device Classification Panel (the 1979 Panel) recommended that 
nonroller-type cardiopulmonary bypass blood pumps 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 is attached directly to the cardiopulmonary 
bypass circuit and is used in a clinical environment where excessive 
leakage current can be a serious hazard. The 1979 Panel further noted 
that the device is used with other devices in a system that may be 
hazardous if not satisfactorily assembled, used, or maintained. The 
1979 Panel indicated that general controls alone would not

[[Page 768]]

provide sufficient control over the performance characteristics of the 
device. Additionally, a performance standard would not provide 
reasonable assurance of the safety and effectiveness of the device; the 
Panel noted further that there was not sufficient information to 
establish a standard to provide such assurance. Consequently, the 1979 
Panel believed that premarket approval was necessary to assure the 
safety and effectiveness of the device. In 1980, FDA classified 
nonroller-type cardiopulmonary bypass blood pumps into class III after 
receiving no comments on the proposed rule (45 FR 7959, February 5, 
1980).
    In 1987, FDA published a clarification by inserting language in the 
codified language stating that no effective date had been established 
for the requirement for premarket approval for nonroller-type 
cardiopulmonary bypass blood pumps (52 FR 17732, May 11, 1987).
    On July 6, 1993, FDA published a proposed rule to establish an 
effective date of requirement for premarket approval (i.e. call for 
PMAs) for nonroller-type cardiopulmonary bypass blood pumps, and 
provided an opportunity to request a change in classification in the 
form of a reclassification petition (58 FR 36290). On July 21, 1993, 
FDA received a reclassification petition from manufacturers of these 
devices recommending reclassification to class II (special controls). 
On August 21, 1995, FDA convened the Circulatory System Devices 
Classification Panel (the 1995 Panel) to review the proposed 
reclassification and proposed special controls for nonroller-type 
cardiopulmonary blood pumps for use in cardiopulmonary bypass circuits 
for periods of up to 6 hours. Reclassification to class II with special 
controls was supported by the 1995 Panel for nonroller-type 
cardiopulmonary blood pumps for use in cardiopulmonary bypass circuits 
for periods of up to 6 hours. FDA did not issue a final regulation 
codifying the proposed reclassification. In 2004, the July 6, 1993, 
proposed rule (58 FR 36290) was withdrawn because the proposed rule was 
no longer considered a viable candidate for final action, due to the 
length of time that had elapsed since the proposed rule was issued (69 
FR 68831, November 26, 2004).
    In 2009, FDA published an order for the submission of information 
on nonroller-type cardiopulmonary bypass blood pumps by August 7, 2009 
(74 FR 16214, April 9, 2009). FDA received seven responses to that 
order from device manufacturers. All manufacturers recommended that 
nonroller-type cardiopulmonary bypass blood pumps be reclassified to 
class II. The manufacturers stated that data available in the clinical 
literature, preclinical and clinical testing, additional knowledge and 
information regarding the clinical use of the devices, and the overall 
number of marketed devices provide reasonable assurance of safety and 
effectiveness of these devices.
    As explained further in sections VII and XI of this document, a 
meeting of the Circulatory System Devices Panel (the 2012 Panel) took 
place December 6, 2012, to discuss whether nonroller-type 
cardiopulmonary bypass blood pump devices should be reclassified or 
remain in class III. The 2012 Panel recommended that nonroller-type 
cardiopulmonary bypass blood pump devices for cardiopulmonary and 
circulatory bypass be reclassified to class II with special controls, 
and nonroller-type cardiopulmonary bypass blood pump devices for 
temporary ventricular support remain in class III because the device is 
life-supporting and there was insufficient information to establish 
special controls for this use. FDA is not aware of new information that 
would provide a basis for a different recommendation or findings.

IV. Proposed Reclassification

    FDA is proposing that NRP devices used to propel blood within 
temporary (i.e. less than 6 hours) extracorporeal cardiopulmonary and 
circulatory bypass circuits 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 21 CFR 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 NRP 
Devices for Temporary Cardiopulmonary and Circulatory Bypass into class 
II. 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 NRP Devices for Temporary 
Cardiopulmonary and Circulatory Bypass.
    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 NRP Devices for Temporary Cardiopulmonary and 
Circulatory Bypass 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.
    Because NRP Devices for Temporary Cardiopulmonary and Circulatory 
Bypass 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 NRP Devices for Temporary 
Cardiopulmonary and Circulatory Bypass.

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 NRP Devices for Temporary Cardiopulmonary 
and Circulatory Bypass and determined that the following risks to 
health are associated with their use:
     Alteration in blood composition: It is essential that the 
flow characteristics, heat generated by the pump within the 
extracorporeal circuit, materials, surface finish, and/or cleanliness 
of the device do not promote blood component trauma. Resulting 
complications could include bleeding, hemolysis, thrombus formation, 
and/or complement activation. Improper mechanical design of the device 
can also result in such complications.
     Inadequate tissue perfusion: If the design of the pump is 
improper, or the pump is unable to pump blood adequately through a 
cardiopulmonary bypass circuit, inadequate organ perfusion can result. 
Limb ischemia, access vessel injury, or dissection resulting in 
ischemia can result from peripheral cardiopulmonary bypass access.
     Embolism: Improper design of the device may cause the 
generation of

[[Page 769]]

gaseous, particular, or thrombotic emboli, which can result in 
debilitating or fatal complications such as stroke, peripheral emboli, 
or death.
     Use beyond intended duration: Use of the pump beyond the 
intended duration can result in more frequent and severe adverse 
effects.
     Fluid leakage: If the structural integrity of the pump is 
compromised, fluid leakage may result.
     Adverse tissue reaction: Inadequate compatibility of the 
patient-contacting materials of the device may cause physical damage to 
the blood components, or may cause an adverse immunological or allergic 
reaction in a patient.
     Infection: Defects in the design or construction of the 
device preventing adequate cleaning and/or sterilization can allow 
pathogenic organisms to be introduced and can cause an infection in a 
patient.

VI. Summary of Reasons for Reclassification

    If properly manufactured and used as intended, NRP Devices for 
Temporary Cardiopulmonary and Circulatory Bypass can provide a 
treatment option for patients when used for cardiopulmonary bypass by 
providing propulsion of blood through cardiopulmonary bypass circuits 
or when used for circulatory bypass by allowing planned surgical 
disruptions of the circulation to avoid distal organ ischemia or venous 
hypertension. FDA believes NRP Devices for Temporary Cardiopulmonary 
and Circulatory Bypass should be reclassified from class III to class 
II because special 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. FDA believes that the risks to health identified in section 
V associated with NRP Devices for Temporary Cardiopulmonary and 
Circulatory Bypass can be mitigated with general and special controls. 
FDA has identified the risks to health in the table that follows, and 
the special controls to mitigate these identified risks.

------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Alteration in Blood Composition........  Nonclinical Performance/Bench
                                          Testing Labeling.
Inadequate Tissue Perfusion............  Nonclinical Performance/Bench
                                          Testing Labeling.
Embolism...............................  Nonclinical Performance/Bench
                                          Testing Labeling.
Duration of Use........................  Labeling.
Fluid Leakage..........................  Nonclinical Performance/Bench
                                          Testing.
Adverse Tissue Reaction................  Biocompatibility.
Infection..............................  Sterility and Shelf-Life
                                          Testing.
------------------------------------------------------------------------

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 NRP 
Devices for Temporary Cardiopulmonary and Circulatory Bypass to class 
II with special controls. FDA has been reviewing these devices for many 
years and their risks are well known. FDA conducted a comprehensive 
review of available literature for NRP Devices for Temporary 
Cardiopulmonary and Circulatory Bypass. FDA's review found 18 studies, 
including 1 randomized controlled study (RCT), 1 meta-analysis, 4 
cohort studies, and 12 case studies, which provided consistent evidence 
of the safety and effectiveness of NRP Devices for Temporary 
Cardiopulmonary Bypass. Further, FDA's review found 23 studies related 
to NRP Devices for Temporary Circulatory Bypass, including studies 
related to both venovenous bypass and aortic procedures, which provided 
consistent evidence of the safety and effectiveness of NRP Devices for 
Temporary Circulatory Bypass.
    The literature data support that the overall complication rates for 
NRP Devices for Temporary Cardiopulmonary Bypass is similar to that of 
another class II device type, roller-type cardiopulmonary bypass blood 
pumps (21 CFR 870.4370). For example, a meta-analysis of 18 RCTs by 
Saczkowski et al. obtained pooled estimates for a number of clinical 
outcome measures (Ref. 1). This meta-analysis represented 1,868 adult 
patients undergoing cardiopulmonary bypass using either a roller pump 
(907) or a centrifugal pump (961), undergoing predominantly coronary 
bypass graft surgery (87 percent and 88 percent, respectively). 
Patients that underwent a cardiopulmonary bypass procedure either using 
NRPs or roller pumps had no differences in mortality (n = 1,080, odds 
ratio (OR): 1.05, 95 percent confidence interval (CI): 0.58, 1.88), 
bleeding (mean difference: -10.26 mL, 95 percent CI: -54.28, 33.75), 
and blood transfusion (OR: 1.11, 95 percent CI: 0.64, 1.92) at the end 
of cardiopulmonary bypass or 1 day after the procedure. Similarly, no 
statistically significant differences were found on other safety 
endpoints reported (postoperative atrial fibrillation, cerebral damage, 
platelet count, hemoglobin, white blood cell count, hematocrit, 
intensive care unit length of stay, hospital length of stay, and 
neurologic outcomes). Additionally, Parolari et al. published a cohort 
study of 4,000 patients that demonstrated that patients that had 
cardiopulmonary bypass with either a centrifugal pump or a roller pump 
had the same in-hospital mortality (2 percent) (Ref. 2). Multivariate 
results showed that patients who underwent cardiopulmonary bypass with 
the centrifugal pump had a reduction in perioperative permanent 
neurological deficit and perioperative coma of 43 percent and 54 
percent, respectively, compared to those patients that had a circuit 
utilizing a roller pump (p < 0.05).
    The literature data also support the effectiveness of NRP Devices 
for Temporary Cardiopulmonary Bypass. Based on FDA's analysis, the most 
common indicators of effectiveness were length of stay at the hospital, 
length of stay in the intensive care unit (ICU), and duration of 
intubation. In Saczkowski's meta-analysis (Ref. 1), no statistically 
significant differences were found between the NRPs and roller pumps' 
pooled estimates in intensive care unit length of stay and hospital 
length of stay. Intubation time among these patients ranged from 8 
hours to more than 1 day. Similarly, Zirbel et al. did not find 
significant differences in a small cohort study in the hospital and ICU 
length of stay and intubation time among patients on cardiopulmonary 
bypass with a selected centrifugal pump as compared to those on a 
roller pump (Ref. 3).
    The safety and effectiveness of NRPs Devices for Temporary 
Circulatory Bypass during surgical procedures on

[[Page 770]]

the descending thoracic or thoracoabdominal aorta have been reported by 
numerous authors (Refs. 4-9). These devices have supplanted the use of 
passive shunts (e.g., Gott shunt) due to their ability to provide more 
reliable and controllable flow to the distal aorta and the organs it 
perfuses during planned proximal surgical disruptions. In general, 
centrifugal pumps used for temporary circulatory bypass in these 
procedures have provided additional margins of safety by allowing for 
completion of these procedures in a less rushed fashion and without 
full cardiopulmonary bypass (and full heparinization). Additionally, 
use of NRPs has been shown to decrease the incidence of distal organ 
malperfusion and paraplegia, especially during prolonged cross-clamp 
intervals (>30-45 minutes) and reduce transfusion requirements. Use of 
NRPs for circulatory bypass has not been associated with significant 
adverse events related to the centrifugal pump such as thrombosis, 
thromboembolism, or cannulation-related injuries.
    The literature data outlined in this document support a conclusion 
of reasonable evidence for the safety and effectiveness of 
cardiopulmonary and circulatory bypass blood pump devices. In addition, 
bench studies designed to demonstrate the devices' ability to function 
as intended have been well characterized.
    FDA's presentation to the 2012 Panel included a summary of the 
available safety and effectiveness information for NRP Devices for 
Temporary Cardiopulmonary and Circulatory Bypass, including identified 
risks to health drawn from adverse event reports from FDA's 
Manufacturer and User Facility Device Experience (MAUDE) database and 
available literature. Based on the available scientific literature, 
which supports that use of NRP Devices for Temporary Cardiopulmonary 
and Circulatory Bypass may be beneficial for patients requiring 
cardiopulmonary or circulatory bypass, FDA recommended to the 2012 
Panel that NRP Devices for Temporary Cardiopulmonary and Circulatory 
Bypass 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 NRP Devices for 
Temporary Cardiopulmonary and Circulatory Bypass.
    The 2012 Panel also acknowledged that NRP Devices for Temporary 
Cardiopulmonary and Circulatory Bypass are life-supporting devices and 
provided the following rationale for recommending that NRP Devices for 
Temporary Cardiopulmonary and Circulatory Bypass be reclassified to 
class II: (1) The available scientific evidence supports an adequate 
assurance of safety and effectiveness for the device; (2) there is 
evidence that the device provides hemodynamic support; and (3) the 
recommended special controls will mitigate the health risks associated 
with the device.
    The 2012 Panel agreed with the identified risks to health presented 
at the meeting but also recommended that limb ischemia, access vessel 
injury, and dissection resulting in ischemia related to cardiopulmonary 
bypass access be considered in the risks to health. FDA agrees with the 
2012 Panel's recommendation and modified the risks to health 
accordingly as outlined in section V of this document. Specifically, 
the definition of ``inadequate tissue perfusion'' was expanded to 
include these events. The 2012 Panel also agreed with FDA's proposed 
special controls outlined in section VIII of this document. The 2012 
Panel transcript and other meeting materials are available on FDA's Web 
site (Ref. 10).

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 of this document:
    1. Nonclinical performance testing must provide a reasonable 
assurance of safety and effectiveness with respect to the operating 
parameters, dynamic blood damage, heat generation, air entrapment, 
mechanical integrity, and durability/reliability to perform as intended 
over the intended duration of use;
    2. The device must be demonstrated to be biocompatible;
    3. Sterility and shelf-life testing must demonstrate the sterility 
of patient-contacting components and the shelf-life of these 
components; and
    4. Labeling must include information regarding the duration of use 
and a detailed summary of the device- and procedure-related 
complications pertinent to use of the device.
    NRP Devices for Temporary Cardiopulmonary and Circulatory Bypass 
are prescription devices restricted to patient use only upon the 
authorization of a practitioner licensed by law to administer or use 
the device. (Proposed 21 CFR 870.4360(a)(1); see 21 CFR 801.109 
(Prescription devices)).

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 for NRP Devices for 
Temporary Ventricular Support within 90 days after issuance of any 
final order based on this proposal. 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 temporary ventricular support, and for which the device technology 
would allow such device to be used for cardiopulmonary or circulatory 
bypass, may remove such intended use from the device's labeling by 
initiating a correction within 90 days after issuance of any final 
order based on this proposal. Under 21 CFR part 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.
    FDA intends that under Sec.  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 Sec.  812.2(c)(1) and (c)(2) will 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

[[Page 771]]

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 Sec.  812.30. FDA, therefore, recommends that IDE applications be 
submitted to FDA at least 30 days before the end of the 90-day period 
after the issuance of the final order to avoid interrupting any ongoing 
investigations.

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 when used for temporary ventricular 
support, and (2) the benefits to the public from the use of NRP Devices 
for Temporary Ventricular Support. 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 
device type is discussed in Section XI of this order and can be found 
in 44 FR 13409, March 9, 1979; 45 FR 7959, February 5, 1980; 52 FR 
17732, May 11, 1987; 58 FR 36290, July 6, 1993; and 69 FR 68831, 
November 26, 2004.

XI. Device Subject to the Proposal To Require a PMA--Nonroller-Type 
Temporary Ventricular Support Blood Pump Devices (21 CFR 870.4360(c))

A. Identification

    An NRP Device for Temporary Ventricular Support is a prescription 
device that uses any method resulting in blood propulsion to provide 
the temporary (i.e. <= 6 hours) ventricular assistance required for 
support of the systemic and/or pulmonary circulations during periods 
when there is ongoing or anticipated hemodynamic instability due to 
immediately reversible alterations in ventricular myocardial function 
resulting from mechanical or physiologic causes.

B. Summary of Data

    The use of NRP Devices for Temporary Ventricular Support does not 
share the long history of use compared to NRP Devices for Temporary 
Cardiopulmonary or Circulatory Bypass. Temporary NRP devices, when used 
for cardiopulmonary or circulatory bypass, are integral to the 
underlying procedure (e.g., open heart surgery, resection of thoracic 
aneurysm) itself, making it both possible and safer. When used for 
temporary ventricular support, the NRP devices introduce the risk of 
both the blood pump and its access technology in procedures where a 
substantial portion of patient benefit is derived or thought to be 
derived from the avoidance of circulatory support or bypass, or from 
the safer performance of the underlying procedure (e.g., percutaneous 
coronary intervention, off pump coronary artery bypass). Based on FDA's 
review of available data, use of the device is associated with 
significant procedural risks. These risks do not appear to be balanced 
by a demonstrable clinical benefit. Specifically, based on FDA's review 
of the published literature, it appears that there are no completed 
studies regarding use of NRP devices that support the effectiveness for 
temporary ventricular support. Further, the 2011 American College of 
Cardiology Foundation/American Heart Association/Society for 
Cardiovascular Angiography and Interventions (ACCF/AHA/SCAI) Guideline 
for Percutaneous Coronary Intervention assigned a class IIb, Level C 
recommendation to the use of temporary ventricular support devices for 
high-risk percutaneous coronary interventions. A Class IIb, level C 
indication means that the benefit may outweigh the risk and that the 
treatment or procedure may be considered. This recommendation's 
usefulness or efficacy is unknown/unclear/uncertain or not well 
established and is based only on diverging expert opinion, case 
studies, or standard of care (Ref. 11). When used for temporary 
ventricular support, FDA concludes that the safety and effectiveness of 
NRP devices have not been established by adequate scientific evidence. 
The benefit/risk profile for NRP Devices for Temporary Ventricular 
Support indications is unknown. Further, safe and effective performance 
parameters for the class of devices have not been established by data. 
For these reasons, FDA does not believe sufficient information exists 
to establish special controls to provide a reasonable assurance of 
safety and effectiveness for the devices.
    FDA presented findings regarding NRP Devices for Temporary 
Ventricular Support to the Circulatory System Devices Panel (the Panel) 
on December 6, 2012. The Panel recommended that available scientific 
evidence is not adequate to support the safety and effectiveness of NRP 
Devices Temporary Ventricular Support and that these devices fit the 
criteria necessary to remain in class III because (1) the devices are 
life-supporting and (2) insufficient information exists to determine 
that special controls would provide reasonable assurance of its safety 
and effectiveness for this use. As a result, the Panel concluded that 
NRP Devices for Temporary Ventricular Support should remain in class 
III (subject to premarket approval application). The Panel transcript 
and other meeting materials are available on FDA's Web site (Ref. 11).

C. Risks to Health

    The risks to health for NRP Devices for Temporary Ventricular 
Support include the risks outlined in section V as well as the 
following additional risks to health:
     Structural/tissue damage: Improper design, placement, or 
use of the percutaneous device or access cannulae can cause structural 
or tissue damage to the heart or access vessels, including perforation, 
dissection, tamponade, and/or valve damage.
     Intracardiac heat generation: Improper design of the 
device may cause excessive heat generation within the heart or great 
vessels, which can cause tissue damage and can affect hemolysis and 
thromboembolic potential.
     Modified flow dynamics: Improper design or placement of 
the percutaneous device or cannulae can cause new or different patterns 
or methods of flow, which can affect hemolysis or thromboembolic 
potential, or can cause limb ischemia due to the need for peripheral 
cannulation with large bore cannulae.
    These additional risks to health are directly related to the NRP 
technology that, for temporary use, requires percutaneous placement of 
either a pump containing catheter or separate inflow and outflow 
cannulae into the heart or great vessels. For effective use, these pump 
containing catheters or access cannulae must either reside in and/or 
traverse one or more elements of the circulation (i.e. great vessels, 
valves, septa). In contrast, temporary NRP devices that are used as 
part of an extracorporeal cardiopulmonary bypass or circulatory bypass 
circuit do not present these risks to health since the actual NRP 
resides outside of the circulation, and the cannulae required for 
inflow and outflow are placed under direct visualization into the 
central circulation during an open surgical procedure without being 
required to traverse one or more cardiac chambers, septa, or valves for 
effective use.

[[Page 772]]

D. Benefits of NRP Devices for Temporary Ventricular Support

    As discussed previously, there is limited scientific evidence 
regarding the effectiveness of NRP Devices for Temporary Ventricular 
Support. Because the benefits of NRP Devices for Temporary Ventricular 
Support are unknown, it is impossible to estimate the direct effect of 
the devices on patient outcomes. However, NRP Devices for Temporary 
Ventricular Support have the potential to benefit the public by 
providing cardiac support, improving hemodynamic stability, reducing 
myocardial workload and oxygen consumption, and increasing cardiac 
output. Their use may also allow initiation or completion of complex 
therapies, recovery of native ventricular function sufficient for 
weaning of the device, or bridging to more permanent therapies meant to 
provide long-term hemodynamic support.

XII. PMA Requirements

    A PMA for NRP Devices for Temporary Ventricular Support must 
include the information required by section 515(c)(1) of the FD&C Act 
and 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 Sec.  860.7(c)(1)). In particular, a PMA for the 
device should discuss the benefits of the device in light of the risks 
identified in this document. Valid scientific evidence is ``evidence 
from well-controlled investigations, partially controlled studies, 
studies and objective trials without matched controls, well-documented 
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 Sec.  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 NRP Devices for 
Temporary Ventricular Support is to be in the form of a 
reclassification petition containing the information required by 21 CFR 
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 (CFR). 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 21 
CFR 870.4360 related to the classification of nonroller-type 
cardiopulmonary bypass blood pump devices as class III devices and to 
codify the reclassification of nonroller-type cardiopulmonary and 
circulatory bypass blood pump devices into class II.

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.

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. To 
account for this change, FDA intends to transfer some of the burden 
from OMB control number 0910-0120, which is the control number for the 
510(k) premarket notification process, to OMB control number 0910-0231, 
which is the control number for the PMA process. As noted previously, 
FDA estimates that it will receive three new PMAs as a result of this 
order, if finalized. Based on FDA's most recent estimates, this will 
result in 1,038 hours burden increase to OMB control number 0910-0231. 
FDA also estimates that there will be three fewer 510(k) submissions as 
a result of this order, if finalized. Based on FDA's most recent 
estimates, this will result in a 136 hours burden decrease to OMB 
control number 0910-0120. Therefore, on net, FDA expects a burden hour 
increase of 901 hours due to this proposed regulatory change.

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 docket number 
found in 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.

XIX. References

    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

[[Page 773]]

section, but FDA is not responsible for any subsequent changes to the 
Web site after this document publishes in the Federal Register.)

1. Saczkowski, R., M. Maklin, T. Mesana, et al., ``Centrifugal Pump 
and Roller Pump in Adult Cardiac Surgery: A Meta-Analysis of 
Randomized Controlled Trials,'' Artificial Organs, vol. 36, pp. 668-
676, 2012.
2. Parolari, A., F. Alamanni, M. Naliato, et al., ``Adult Cardiac 
Surgery Outcomes: Role of the Pump Type,'' European Journal of 
Cardiothoracic Surgery, vol. 18, pp. 575-582, 2000.
3. Zirbel, G.M., M.E. Letson, J.N. Kauffman, et al., ``Hematologic 
Derangements of Cardiopulmonary Bypass: A Comparison of Two 
Perfusion Systems,'' The Journal of Extra-Corporeal Technology, vol. 
22, pp. 15-19, 1990.
4. Schepens, M.A., F.E. Vermeulen, W.J. Morshuis, et al., ``Impact 
of Left Heart Bypass on the Results of Thoracoabdominal Aortic 
Aneurysm Repair,'' The Annals of Thoracic Surgery, vol. 67, pp. 
1963-1967; discussion pp. 1979-1980, 1999.
5. Szwerc, M.F., D.H. Benckart, J.C. Lin, et al., ``Recent Clinical 
Experience With Left Heart Bypass Using a Centrifugal Pump for 
Repair of Traumatic Aortic Transection,'' Annals of Surgery, vol. 
230, pp. 484-490; discussion pp. 490-492, 1999.
6. Ataka, K., M. Okada, C. Yamashita, et al., ``Beneficial 
Circulatory Support by Left Heart Bypass With a Centrifugal 
(BioMedicus) Pump for Aneurysms of the Descending Thoracic Aorta,'' 
Artificial Organs, vol. 17, pp. 300-306, 1993.
7. Galla, J.D., M.A. Ergin, A.M. Sadeghi, et al., ``A New Technique 
Using Somatosensory Evoked Potential Guidance During Descending and 
Thoracoabdominal Aortic Repairs,'' Journal of Cardiac Surgery, vol. 
9, pp. 662-672, 1994.
8. Hess, P.J., H.R. Howe, Jr., and F. Robicsek, ``Traumatic Tears of 
the Thoracic Aorta: Improved Results Using the Bio-Medicus Pump,'' 
The Annals of Thoracic Surgery, vol. 48, pp. 6-9, 1989.
9. Cunningham, I.N., J.C. Laschinger, and F.C. Spencer, ``Monitoring 
of Somatosensory Evoked Potentials During Surgical Procedures on the 
Thoracoabdominal Aorta: Clinical Observations and Results,'' Journal 
of Thoracic and Cardiovascular Surgery, vol. 94, pp. 275-285, 1987.
10. The 2012 Panel transcript and other meeting materials are 
available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm300073.htm.
11. Levine, G.N., E.R. Bates, J.C. Blankenship, et al., ``2011 ACCF/
AHA/SCAI Guideline for Percutaneous Coronary Intervention: A Report 
of the American College of Cardiology Foundation/American Heart 
Association Task Force on Practice Guidelines and the Society for 
Cardiovascular Angiography and Interventions,'' Journal of the 
American College of Cardiology, vol. 58, pp. e44-e122, 2011.

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

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.  870.4360 to read as follows:

Sec.  870.4360  Nonroller-type blood pump.

    (a) Cardiopulmonary and circulatory bypass blood pump--(1) 
Identification. A nonroller-type cardiopulmonary and circulatory bypass 
blood pump is a prescription device that uses a method other than 
revolving rollers to pump the blood through an extracorporeal circuit 
for periods lasting less than 6 hours for the purpose of providing 
either:
    (i) Full or partial cardiopulmonary bypass (i.e. circuit includes 
an oxygenator) during open surgical procedures on the heart or great 
vessels, or
    (ii) Temporary circulatory bypass for diversion of flow around a 
planned disruption of the circulatory pathway necessary for open 
surgical procedures on the aorta or vena cava.
    (2) Classification. Class II (special controls). The special 
controls for this device are:
    (i) Nonclinical performance testing must provide a reasonable 
assurance of safety and effectiveness with respect to the operating 
parameters, dynamic blood damage, heat generation, air entrapment, 
mechanical integrity, and durability/reliability to perform as intended 
over the intended duration of use;
    (ii) The device must be demonstrated to be biocompatible;
    (iii) Sterility and shelf-life testing must demonstrate the 
sterility of patient-contacting components and the shelf-life of these 
components; and
    (iv) Labeling must include information regarding the duration of 
use, and a detailed summary of the device- and procedure-related 
complications pertinent to use of the device.
    (b) Temporary ventricular support blood pump.--(1) Identification. 
A nonroller-type temporary ventricular support blood pump is a 
prescription device that uses any method resulting in blood propulsion 
to provide the temporary ventricular assistance required for support of 
the systemic and/or pulmonary circulations during periods when there is 
ongoing or anticipated hemodynamic instability due to immediately 
reversible alterations in ventricular myocardial function resulting 
from mechanical or physiologic causes. Duration of use would be less 
than 6 hours.
    (2) Classification. Class III (premarket approval).
    (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 90 DAYS AFTER DATE OF PUBLICATION OF A 
FUTURE FINAL ORDER IN THE Federal Register], for any temporary 
ventricular support blood pump that was in commercial distribution 
before May 28, 1976, or that has, on or before [A DATE WILL BE ADDED 90 
DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER IN THE Federal 
Register], been found to be substantially equivalent to any temporary 
ventricular support blood pump that was in commercial distribution 
before May 28, 1976. Any other temporary ventricular support blood pump 
shall have an approved PMA or declared completed PDP in effect before 
being placed in commercial distribution.

    Dated: January 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00027 Filed 1-6-14; 8:45 am]
BILLING CODE 4160-01-P