Document ID: FDA-2013-N-1518-0002
Agency: fda
Document Type: 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: 2015-06-08T04:00Z

[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Rules and Regulations]
[Pages 32307-32311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13889]

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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: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
order to reclassify nonroller-type cardiopulmonary bypass blood pump 
(NRP) devices for cardiopulmonary and circulatory bypass, a 
preamendments class III device, into class II (special controls), and 
to require the filing of a premarket approval application (PMA) for NRP 
devices for temporary ventricular support. FDA is also revising the 
title and identification of the regulation for NRP devices in this 
order.

DATES: This order is effective June 8, 2015.

FOR FURTHER INFORMATION CONTACT: Fernando Aguel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1234, Silver Spring, MD 20993, 301-796-6326, 
fernando.aguel@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), among other amendments, 
established a comprehensive system for the regulation of medical 
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 
360c) established three categories (classes) of devices, reflecting the 
regulatory controls needed to provide reasonable assurance of their 
safety and effectiveness. The three categories of devices are class I 
(general controls), class II (special controls), and class III 
(premarket approval).
    Under section 513(d) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
May 28, 1976 (generally referred to as ``preamendments devices''), are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee) (the Panel); (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

[[Page 32308]]

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 (both the preamendments and substantially 
equivalent devices are referred to as ``preamendments class III 
devices'') 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 class III 
preamendments device may respond to the call for PMAs by filing a PMA 
or a notice of completion of a product development protocol (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 process 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 process for requiring premarket approval for a 
preamendments class III device from rulemaking to an administrative 
order.

A. Reclassification

    FDA is reclassifying NRP devices for cardiopulmonary and 
circulatory bypass from class III to class II (special controls) and 
renaming these devices from ``Nonroller-type cardiopulmonary bypass 
blood pump'' to ``Nonroller-type blood pump.''
    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 at 214 (D.C. Cir. 1985); Contact Lens 
Manufacturers Association v. FDA, 766 F.2d at 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 non-clinical 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 held a meeting of a device classification panel 
described in section 513(b) of the FD&C Act with respect to NRP devices 
on December 6, 2012 (Ref. 1). The Panel unanimously recommended that 
NRP devices for cardiopulmonary and circulatory bypass be reclassified 
from class III to class II with special controls because the 
application of general and special controls are sufficient to provide 
reasonable assurance of safety and effectiveness for NRP devices when 
intended for these uses. The Panel believed that the special controls 
identified by FDA were appropriate to mitigate the relevant risks to 
health for these uses. FDA published a proposed order in the Federal 
Register on January 7, 2014 (79 FR 765). FDA received and has 
considered two comments on the proposed order as discussed in section 
II of this document (Ref. 2).

B. Requirement for Premarket Approval Application

    FDA is requiring PMAs for NRP 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.
    FDA held a meeting of a device classification panel described in 
section 513(b) of the FD&C Act with respect to NRP devices on December 
6, 2012 (Ref. 1). The majority of the Panel recommended that NRP 
devices for temporary ventricular support remain in class III (subject 
to premarket approval application) because there was insufficient 
information to establish special controls, and that the application of 
general controls is insufficient to provide a reasonable assurance of 
safety and effectiveness for NRP devices, which are life-supporting 
devices (Ref. 2).
    FDA published a proposed order in the Federal Register of January 
7, 2014, that satisfied the requirements of section 515(b)(2) of the 
FD&C Act, which provides that a proposed order to require premarket 
approval shall contain: (1) The proposed order; (2) proposed findings 
with respect to the degree of risk of illness or injury designed to be 
eliminated or reduced by

[[Page 32309]]

requiring the device to have an approved PMA and the benefit to the 
public from the use of the device; (3) an opportunity for the 
submission of comments on the proposed order and the proposed findings; 
and (4) an opportunity to request a change in the classification of the 
device based on new information relevant to the classification of the 
device. FDA received and has considered two comments on the proposed 
order as discussed in section II of this document.
    A preamendments class III device may be commercially distributed 
without a PMA until 90 days after FDA issues a final order 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. Since NRP devices (the preamendments class III 
devices that are the subject of this final order) were classified in 
1980, the 30-month period has expired (45 FR 7959, February 5, 1980). 
Thus, for these devices, the later of these two time periods is the 90-
day period. Therefore, section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 
351(f)(2)(B)) requires that a PMA for such devices be filed within 90 
days of the date of issuance of this final order. If a PMA is not filed 
for such devices 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 a call for PMAs 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 for NRP devices for temporary ventricular support. 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 
may be subject to injunction under section 302 of the FD&C Act (21 
U.S.C. 332), and the individuals responsible for such shipment may be 
subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 
333). FDA requests that manufacturers take action to prevent the 
further use of devices for which no PMA has been filed.

II. Public Comments in Response to the Proposed Order

    In response to the January 7, 2014, proposed order to reclassify 
NRP devices for cardiopulmonary and circulatory bypass into class II 
and to require the filing of a PMA for NRP devices for temporary 
ventricular support, FDA received two comments. One comment disagreed 
with FDA's proposal to reclassify NRP devices for cardiopulmonary and 
circulatory bypass as a class II medical device. The comment stated 
general concerns that reclassification would result in the loss of 
important safeguards that are provided by authorities under the PMA 
regime, including proof of safety and efficacy based on short-term 
clinical trials, reporting of postmarket long-term clinical data as a 
condition of approval, inspection of manufacturing facilities prior to 
approval of a device, and the ability to rescind the approval of 
devices if the device is later found to be unsafe. FDA disagrees with 
this comment. Currently, NRP devices are typically regulated through 
the 510(k) pathway; therefore, reclassification of NRP devices for 
cardiopulmonary and circulatory bypass to class II will not result in 
the loss of current safeguards, as the regulatory pathway for these 
devices will remain the same. FDA places a device in the lowest 
classification that would provide reasonable assurance of the safety 
and effectiveness of the device. Under section 513(a)(1)(B) of the FD&C 
Act, a class II device is defined as a device which cannot be 
classified as a class I device because the general controls by 
themselves are insufficient to provide reasonable assurance of the 
safety and effectiveness of the device, and for which there is 
sufficient information to establish special controls to provide such 
assurance. The Panel recommended that NRP devices for cardiopulmonary 
and circulatory bypass be classified as class II because they believed 
that there is significant knowledge and data regarding the safety and 
effectiveness of NRP devices for cardiopulmonary and circulatory 
bypass, based on the device's long history of use in cardiopulmonary 
and circulatory bypass procedures (Ref. 2). The Panel believed that the 
application of general and special controls is sufficient to provide 
reasonable assurance of safety and effectiveness for NRP devices for 
cardiopulmonary and circulatory bypass (Ref. 2). FDA agrees with the 
Panel's recommendation and believes that because special controls are 
able to provide a reasonable assurance of safety and effectiveness, the 
requirement of a PMA for these devices is not necessary. By contrast, 
the majority of the Panel believed there remains insufficient valid 
scientific evidence to determine that general and special controls 
would provide a reasonable assurance of safety and effectiveness of NRP 
devices for temporary ventricular support. FDA agrees with the Panel's 
recommendation and as a result, NRP devices for temporary ventricular 
support will remain in class III and require premarket approval.
    Another comment supported FDA's proposal to call for PMAs for NRP 
devices for temporary ventricular support, but disagreed with FDA's 
intent to reclassify NRP devices for cardiopulmonary and circulatory 
bypass, stating that ``down-classification . . . would create an 
enormous and dangerous loophole'' by which devices cleared by the 
510(k) process for a ``particular indication'' could be used ``off-
label for treatments that require a PMA.'' FDA notes in response to 
this comment that generally, FDA regulates the use of a device as 
indicated by the party offering the device for interstate commerce. The 
indications for NRP devices for cardiopulmonary and circulatory bypass 
will be limited by the codified identification in Sec.  870.4360(a)(1) 
(21 CFR 870.4360(a)(1)).
    The commenter also expressed concern that special controls were 
insufficient to mitigate the risk of stroke, peripheral emboli, or 
death associated with NRP devices for cardiopulmonary and circulatory 
bypass. FDA disagrees with the commenter. Under 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; (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 that is of substantial 
importance in preventing impairment of human health, or presents a 
potential unreasonable risk of illness or injury. FDA believes that 
sufficient information exists for NRP devices used for

[[Page 32310]]

cardiopulmonary and circulatory bypass to establish special controls 
that, together with general controls, can provide a reasonable 
assurance of safety and effectiveness and mitigate the risks to health 
identified in the proposed order (79 FR 765 at 769, January 7, 2014). 
Stroke, peripheral emboli, and death are potential clinical 
consequences of the identified risks to health and are therefore 
addressed by mitigating the risks to health through the general and 
special controls. Specifically, in the proposed order (79 FR 765 at 
769), FDA determined that embolism was a risk to health associated with 
use of NRP devices for temporary cardiopulmonary and circulatory 
bypass. We explicitly noted that improper design of the device may 
cause the generation of gaseous, particular, or thrombotic emboli, 
which can result in debilitating or fatal complications such as stroke, 
peripheral emboli, or death. However, this risk to health is mitigated 
through non-clinical performance testing and labeling (special controls 
(a)(2)(i) and (iv) in the codified section of this document). Non-
clinical performance testing evaluates the design of the device to 
ensure that the device does not generate gaseous, particular, or 
thrombotic emboli, which could cause stroke, peripheral emboli, or 
death. Further, the labeling will provide information regarding the 
duration of use to minimize the risk of embolism. The Panel concluded 
that these special controls were sufficient to mitigate the identified 
risks to health and provide reasonable assurance of safety and 
effectiveness for NRP devices for cardiopulmonary and circulatory 
bypass (Ref. 2). FDA agrees with the Panel's recommendation.
    The commenter also provided a summary of adverse event reports for 
this device type from FDA's Manufacturer and User Facility Device 
Experience (MAUDE) database to support the perspective that 
reclassification is inappropriate for NRP devices for cardiopulmonary 
and circulatory bypass. FDA is aware of this data, fully considered 
this information prior to the proposed reclassification, and presented 
the adverse event information to the 2012 Panel that ultimately 
recommended that FDA reclassify NRP devices for cardiopulmonary and 
circulatory bypass from class III to class II (special controls). FDA 
agrees with this recommendation because special controls established by 
this final order can provide a reasonable assurance of safety and 
effectiveness.
    The commenter further expressed concern that ``down-classification 
of these devices means that companies manufacturing new models with 
unique characteristics in the future would not be required to prove 
that their products are safe or effective. The companies would only 
need to prove that their products are substantially equivalent to other 
NRPs for cardiopulmonary and circulatory bypass already on the market, 
and would not require scientific evidence to ensure equivalent safety 
or efficacy.'' FDA disagrees with this comment. FDA believes that the 
special controls will provide a reasonable assurance of safety and 
effectiveness for NRP devices indicated for cardiopulmonary and 
circulatory bypass. Conformance with the identified special controls 
will provide a reasonable assurance of safety and effectiveness for the 
available predicate NRPs when indicated for cardiopulmonary and 
circulatory bypass. Future devices claiming substantial equivalence to 
an available predicate(s) must demonstrate that they are substantially 
equivalent, as defined under section 513(i) of the FD&C Act, to the 
predicate device and comply with all applicable FDA regulations. Future 
devices will also need to comply with the special controls in order to 
be classified into class II.

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 proposed order (79 FR 765). FDA is 
issuing this final order to reclassify NRP devices for cardiopulmonary 
and circulatory bypass from class III to class II and establish special 
controls. In addition, FDA is issuing this final order to require the 
filing of a PMA for NRP devices for temporary ventricular support.
    In accordance with the proposed order, this final order will revise 
the title and identification of the regulation for NRP devices in 21 
CFR part 870 to reflect the different types of NRP devices, their 
respective intended uses, and their respective classifications.

A. NRP Device for Temporary Ventricular Support

    Under the final order, a PMA 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 class III preamendments NRP devices for temporary 
ventricular support that were in commercial distribution before May 28, 
1976, or that have 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 is required to be 
in effect for these 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 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 NRP devices intended for temporary ventricular 
support is not filed on or before the 90th day after the effective date 
of this final order, 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. The device may, however, be distributed for 
investigational use, if the requirements of the IDE regulations (part 
812) are met.

B. NRP Device for Cardiopulmonary and Circulatory Bypass

    Following the effective date of this final order, firms submitting 
a 510(k) premarket notification for a NRP device for cardiopulmonary 
and circulatory bypass must comply with the particular mitigation 
measures set forth in the codified special controls.
    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 NRP devices for cardiopulmonary and circulatory 
bypass, 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, and who does not intend to market such 
device for uses other than cardiopulmonary and circulatory bypass, must 
remove uses other than cardiopulmonary and circulatory bypass from the 
device's labeling and comply with the special controls to remain 
legally on the market.

IV. Environmental Impact

    The Agency has determined under 21 CFR 25.30 (h) and 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.

[[Page 32311]]

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 part 812 have been approved under OMB 
control number 0910-0078; the collections of information in 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) 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 preamendment devices or 
devices found to be substantially equivalent to preamendments devices. 
Sections 513(e) and 515(b) as amended require FDA to issue final orders 
rather than regulations, and FDASIA provided for FDA to revoke 
previously issued regulations by order. FDA will continue to codify 
classifications and reclassifications in the Code of Federal 
Regulations. Changes resulting from final orders will appear in the CFR 
as changes to codified classification determinations or as newly 
codified orders. 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.  870.4360 related to the classification of NRP 
devices for cardiopulmonary and circulatory bypass as class III devices 
and codifying the reclassification of these devices into class II.

VII. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 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 addresses, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

1. FDA Circulatory System Devices Panel of the Medical Devices 
Advisory Committee Meeting, December 5-6, 2012, available at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm327178.htm.
2. Transcript of the December 6, 2012, meeting of the Circulatory 
System Devices Panel, available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM335464.pdf.

List of Subjects in 21 CFR Part 870

    Medical devices.

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

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as 
follows:

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

0
2. Revise Sec.  870.4360 to read as follows:

Sec.  870.4360  Nonroller-type blood pump.

    (a) Nonroller-type 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) Non-clinical performance testing must perform as intended over 
the intended duration of use and demonstrate the following: Operating 
parameters, dynamic blood damage, heat generation, air entrapment, 
mechanical integrity, and durability/reliability;
    (ii) The patient-contacting components of 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) Nonroller-type 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 September 8, 2015, for any nonroller-type temporary ventricular 
support blood pump that was in commercial distribution before May 28, 
1976, or that has, on or before September 8, 2015, been found to be 
substantially equivalent to any nonroller-type temporary ventricular 
support blood pump that was in commercial distribution before May 28, 
1976. Any other nonroller-type temporary ventricular support blood pump 
shall have an approved PMA or declared completed PDP in effect before 
being placed in commercial distribution.

    Dated: June 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13889 Filed 6-5-15; 8:45 am]
 BILLING CODE 4164-01-P