Cardiovascular Devices; Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids, 33128-33134 [2016-12333]

Agencies

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

[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Rules and Regulations]
[Pages 33128-33134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2012-N-1173]


Cardiovascular Devices; Reclassification of External Cardiac 
Compressor; Reclassification of Cardiopulmonary Resuscitation Aids

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
order to reclassify external cardiac compressors (ECC) (under FDA 
product code DRM), a preamendments class III device, into class II 
(special controls). FDA is also creating a separate classification 
regulation for a subgroup of devices previously included within this 
classification regulation, to be called cardiopulmonary resuscitation 
(CPR) aids, and reclassifying these devices from class III to class II 
for CPR aids with feedback and to class I for CPR aids without 
feedback.

DATES: This order is effective on May 25, 2016.

FOR FURTHER INFORMATION CONTACT: Hina Pinto, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1652, 
Silver Spring, MD 20993, 301-796-6351, hina.pinto@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 (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

[[Page 33129]]

effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513(d) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
May 28, 1976 (generally referred to as preamendments devices), are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment by interested persons, 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 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 premarket approval application 
(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.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA 
amended section 513(e) of the FD&C Act, changing the mechanism for 
reclassifying a device from rulemaking to an administrative order.
    Section 513(e) of the FD&C Act provides that FDA may, by 
administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
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. U.S. Dep't of 
Health, Educ. & Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); 
Upjohn Co. 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, 388-91 (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., Gen. 
Med. Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. 
Ass'n v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 
1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the ``valid scientific 
evidence'' upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).)
    Section 513(e)(1) of the FD&C Act sets forth the process for 
issuing a final reclassification order. Specifically, prior to the 
issuance of a final order reclassifying a device, the following must 
occur: (1) Publication of a proposed order in the Federal Register; (2) 
a meeting of a device classification panel described in section 513(b) 
of the FD&C Act; and (3) consideration of comments to a public docket. 
FDA published a proposed order to reclassify this device in the Federal 
Register of January 8, 2013 (78 FR 1162). FDA has held a meeting of a 
device classification panel described in section 513(b) of the FD&C Act 
with respect to ECC devices, including CPR aids, and therefore, has met 
this requirement under section 513(e)(1) of the FD&C Act. As explained 
further in section III, a meeting of a device classification panel (the 
Panel) described in section 513(b) of the FD&C Act took place on 
September 11, 2013, to discuss whether ECC devices, including CPR aids, 
should be reclassified or remain in class III. The Panel recommended 
that ECC and CPR aid devices with feedback be reclassified into class 
II because there was sufficient information to establish special 
controls to provide a reasonable assurance of safety and effectiveness. 
The Panel further recommended that CPR aid devices without feedback be 
reclassified into class I because general controls are sufficient to 
provide a reasonable assurance of safety and effectiveness. FDA 
received and has considered four comments on the proposed order as 
discussed in section II.

II. Public Comments in Response to the Proposed Order

    In response to the January 8, 2013, proposed order to reclassify 
external cardiac compressors (including CPR aid devices), FDA received 
four comments. Two comments submitted were supportive of the proposed 
reclassification of the devices, citing, among other things, their safe 
history of use and the need for such devices in situations with 
inadequate access to professionally trained rescuers.
    (Comment 1) One comment disagreed with FDA's proposal to reclassify 
ECC devices and sought a proposed order confirming their status as 
class III devices and requiring PMAs with data from well-controlled 
clinical trials to ensure that these devices are safe and effective. 
The comment stated that the life-sustaining nature of the device along 
with equivocal existing clinical evidence, including data indicating 
that use of ECC may result in neurological outcomes more severe than 
manual CPR, would support keeping the device in class III. The comment 
stated that classification of ECCs should be reviewed by a device 
classification panel. The comment further suggested that the risks to 
health identified in the proposed order should include death and 
neurological damage, and that there are existing data that use of the 
ECC device or device malfunction can delay the start of compressions 
and that professional first-responders often use the device improperly.
    (Response) FDA disagrees with the comment. FDA acknowledges that 
the data on the use of ECC devices as a replacement to effective manual 
CPR are equivocal; however, the proposed order recommended 
reclassification of the

[[Page 33130]]

device as an adjunct to manual CPR. In this final order, FDA has 
further refined the identification for the device in 21 CFR 870.5200 to 
include ``as an adjunct to manual cardiopulmonary resuscitation (CPR) 
when effective manual CPR is not possible (e.g., during patient 
transport, extended CPR when fatigue may prohibit the delivery of 
effective/consistent compressions to the victim, or when insufficient 
EMS personnel are available to provide effective CPR).'' FDA is only 
reclassifying into class II the ECC devices indicated for use when 
effective manual CPR compressions cannot otherwise be provided by the 
rescuer. In this final order, FDA has further revised the device 
identification and the labeling special controls (see section IV) to 
clarify this intended use.
    It is well-established in the clinical community that CPR, 
including effective compressions, is critical to improve the chances of 
survival for a victim of sudden cardiac arrest (Ref. 1). In such 
circumstances when effective manual CPR compressions cannot be provided 
by the rescuer, use of an ECC device that has been demonstrated to 
provide compressions consistent with the American Heart Association's 
(AHA) ``Guidelines for Cardiopulmonary Resuscitation and Emergency 
Cardiovascular Care'' is warranted (Ref. 1). Although controlled 
clinical trials for adjunctive use might be difficult to conduct 
because denying use of an ECC device on patients in the ``control'' arm 
could decrease their chance for survival, it is well established that 
chest compressions are crucial to maintaining perfusion and that 
compressions of adequate rate and depth are necessary to increase the 
probability of survival in victims of sudden cardiac arrest (Ref. 1). 
As such, FDA believes that these devices, when indicated for use as an 
adjunct to manual CPR during patient transport or for use in situations 
where fatigue of or inaccessibility to emergency medical personnel may 
otherwise prevent adequate chest compressions, can be regulated as 
class II devices. These devices should not be used as a replacement for 
manual CPR.
    FDA presented a modified ECC device identification and the 
available scientific evidence to a device classification panel that 
reached consensus in support of FDA's proposal for reclassification 
(see section III). FDA also presented the risks to health to the Panel, 
and there was consensus support by the Panel of the risks as originally 
identified.
    (Comment 2) This comment also states that FDA failed to properly 
consider death or neurological injury as a health risk associated with 
these devices. However, as discussed in section III, death and 
neurological damage are outcomes already covered by the identified 
risks of ``ineffective compressions.''
    (Response) FDA's presentation to the Panel also included a review 
of adverse events. This review did not reveal a significant number of 
adverse events associated with device malfunction or improper use, 
given the usage of these devices over more than a decade (e.g., 88 
adverse event reports over a 12-year period, with 33 of the 88 
malfunctions occurring in 1 year--2012--which can be attributed to an 
increase in reported problems for one particular device that eventually 
resulted in a recall). Additionally, these issues are also adequately 
addressed with the implementation of special controls related to 
performance data, labeling on appropriate use, and general controls, 
including good manufacturing practices. The Panel also reached 
consensus in support of the special controls, and FDA has modified the 
special controls in response to certain concerns expressed by the 
Panel, including concerns related to potential for use of the ECC 
device to delay CPR (see section III).
    (Comment 3) One comment suggested that CPR aid devices should be 
identified separately from ECC devices, and that CPR aid devices that 
provide feedback solely on compression should be defined separately 
from other CPR aid devices that provide feedback on additional CPR 
parameters, such as ventilation. The comment further suggested that CPR 
aid devices should be made widely available (e.g., ``over-the-
counter'') and are low-risk devices that should be exempt from 
premarket notification (510(k)). The comment noted that the risks to 
health described in the proposed order as well as the proposed special 
controls could instead be covered by general controls, including design 
controls under 21 CFR part 820, and hence classification of these 
devices into class I was appropriate.
    (Response) FDA agrees, in part, with the comment. FDA agrees that 
CPR aid devices are distinct in intended use and technology when 
compared to devices that automatically deliver compressions. In this 
final order, FDA has separated CPR aid devices into a separate 
classification regulation, 21 CFR 870.5210 (see section VI). FDA also 
agrees that availability of these devices over-the-counter is 
appropriate in certain instances when the devices are adequately 
designed and provided with adequate labeling on appropriate use. As 
discussed in this document, FDA has modified the criteria for exemption 
of these devices from premarket notification, and such exemption is no 
longer tied to prescription use as compared to over-the-counter use.
    FDA disagrees, in part, with the comment related to the 
classification of the CPR aid devices. Although, FDA agrees that the 
risks associated with CPR aid devices without feedback can be 
adequately mitigated with general controls, FDA has determined that CPR 
aid devices with feedback require special controls. FDA did consider 
whether it was more appropriate to evaluate the technology contained 
within CPR aid devices and consider appropriate regulatory controls 
based on technological characteristics, as opposed to prescription-use 
and compliance with CPR guidelines as was originally proposed. FDA 
determined that based on technological complexity, some CPR aid devices 
could be appropriately regulated in class I (general controls) and 
class II (special controls). CPR aid devices can be appropriately 
regulated as follows: (1) CPR aid devices without feedback are 
reclassified into class I, (2) CPR aid devices with feedback, but 
without software are reclassified into class II, exempt from submission 
of a 510(k), and (3) CPR aid devices with feedback with software are 
reclassified into class II (special controls), not exempt from 510(k). 
Further, FDA notes that design controls under 21 CFR 820.30 would apply 
to all CPR aid devices with software.
    This final order, therefore, now divides CPR aid devices into those 
without feedback (class I) or with feedback (class II). This approach 
was presented to and supported by the Panel (see section III). CPR aid 
devices that do not provide feedback (e.g., hand positioning aids and 
``metronome'' devices that provide sounds to prompt the rescuer to 
deliver compressions at a rate consistent with CPR guidelines) can be 
regulated in class I, subject to the general controls and generally 
exempt from premarket notification (subject to the limitations of 
exemption contained in Sec.  870.9 (21 CFR 870.9)). FDA continues to 
believe that CPR aid devices that do provide feedback to the rescuer 
(e.g., devices that sit on the patient's chest, underneath the hands of 
the rescuer, to provide feedback on compression rate/depth/etc., or 
devices that provide prompts to the rescuer on appropriate CPR 
sequence) require special controls, in combination with general 
controls, to provide a reasonable assurance of safety and 
effectiveness. FDA acknowledges that some of the specified performance 
testing and other

[[Page 33131]]

special controls requirements will be managed as part of a 
manufacturer's design control process; however, FDA disagrees that the 
general requirements to conform to design controls requirements under 
21 CFR 820.30 are sufficient to ensure that manufacturers will perform 
the tests and other requirements that are necessary as specifically 
identified in the special controls.
    FDA further determined that due to their simple and well-understood 
technological characteristics, exemption from premarket notification 
(510(k)) is appropriate for mechanical or electro-mechanical CPR aid 
devices that provide feedback (e.g., devices that utilize bladders and 
pressure gauges to provide feedback on compression depth), when such 
devices comply with the special controls and subject to the limitations 
of exemption contained in Sec.  870.9. However, devices that contain 
software have complex and evolving levels of visual and audio feedback 
to users, warranting continued review under the 510(k) process.

III. Deliberations of the Panel

    In Session I on September 11, 2013, the Circulatory System Devices 
Panel (the Panel) of the Medical Devices Advisory Committee considered 
the proposed reclassification of ECC devices (Ref. 2). The Panel was 
asked to provide input on the risks to health, safety, and 
effectiveness of ECC devices and CPR aid devices. The Panel was also 
asked to consider FDA's proposed premarket regulatory classification 
strategy for ECC and CPR aid devices, which, for CPR aid devices in 
particular, had been modified based on public comments received on the 
proposed order for ECC devices (see FDA's Panel Executive Summary, Ref. 
2). The regulatory strategy presented to the Panel included: (1) 
Reclassification for ECC devices from class III to class II (special 
controls); (2) reclassification of CPR aid devices without feedback to 
class I (general controls), with over-the-counter access appropriate if 
the device is labeled for professionally trained rescuers; and (3) 
reclassification of CPR aid devices with feedback to class II (special 
controls), with over-the-counter access appropriate if human factors 
testing demonstrates proper use by the intended user identified in the 
labeling (professionally trained and/or untrained lay rescuers).
    The Panel reached consensus in supporting the aforementioned 
classification strategy for CPR aid devices. There was significant 
panel deliberation on reclassification of the automated ECC devices 
that deliver compressions. The Panel expressed concern regarding the 
limited available clinical evidence for these devices. Based on the 
definition of valid scientific evidence in Sec.  860.7(c)(2), which 
allows for ``reports of significant human experience with a marketed 
device, from which it can fairly and responsibly be concluded by 
qualified experts that there is a reasonable assurance of the safety 
and effectiveness of a device under its conditions of use'' and the 
wide clinical knowledge base supporting that effective CPR (including 
compressions) optimize the chance for survival of victims of cardiac 
arrest, the Panel consensus was that it was appropriate to reclassify 
these devices for adjunctive use (e.g., in situations where a rescuer 
cannot provide effective manual compressions). The Panel acknowledged 
that there is insufficient evidence to conclude that ECC devices are as 
effective as manual CPR.
    As discussed at the Panel meeting, FDA has identified the public 
health benefits in using ECC devices (Ref. 2). Automated ECCs are used 
by emergency medical personnel to automate chest compressions during 
CPR. These devices are typically used in situations where extended CPR 
is required, such as during patient transport or when there are an 
inadequate number of trained personnel during extended CPR. FDA 
believes that these devices, when indicated for use as an adjunct to 
manual CPR during patient transport or for use in situations where 
fatigue of or inaccessibility to emergency medical personnel may 
otherwise prevent adequate chest compressions, will serve a public 
health benefit. In the absence of effective chest compressions, death 
is a likely outcome.
    CPR aid devices also have public health benefits because these 
devices are used to remind emergency medical personnel of appropriate 
CPR steps and technique and to provide feedback on the rate and depth 
of compressions (Ref. 2). Specifically, these devices are intended to 
assist the rescuer in providing consistent and effective/optimal CPR, 
and can include instruction, rate, and/or breathing prompts, and real-
time feedback through the duration of CPR and in accordance with 
current accepted CPR guidelines. The AHA guidelines on cardiopulmonary 
resuscitation and emergency cardiovascular care state that ``real-time 
CPR prompting and feedback technology such as visual and auditory 
prompting devices can improve the quality of CPR'' (Ref. 1). CPR aid 
devices are intended to encourage the rescuer to perform consistent and 
optimal CPR over the duration of needed therapy.
    FDA also presented the risks to health to the Panel, and the Panel 
reached consensus in supporting the risks as originally identified with 
the following comments: (1) The risks identified for CPR aid devices 
should also include the same risks as identified for the ECC devices 
because a CPR aid device that provides incorrect feedback can result in 
similar risks as the ECC devices, and (2) death and neurologic injury 
are not specifically identified in the ECC risks. FDA considered the 
Panel's input related to the risks of the device and determined that 
the originally proposed risks of the devices are appropriate. The risks 
to health are those risks directly associated with use of the device. 
The CPR aid device cannot directly cause tissue damage, bone breakage, 
etc. and these risks are a consequence of the application of CPR by a 
rescuer. Moreoever, since ``ineffective compressions'' could result in 
neurological damage and/or death, these risks are adequately covered by 
the identified risk of ``ineffective compressions.''
    The Panel also made recommendations to FDA regarding additional 
special controls for ECC and CPR aid devices including: (1) Disclosure 
of limitations on patient size and/or use population, (2) controls over 
the time necessary to deploy the device, and (3) reinforcing that the 
ECC device is for adjunctive use. FDA agrees with the special control 
recommendations for ECC devices and has revised the special controls 
accordingly; for CPR aid devices, FDA does not believe controls are 
necessary during the time needed to deploy the device since use of 
these devices would not result in a significant delay in administering 
CPR.
    After considering input from the Panel, FDA has determined that the 
risks to health identified for ECC and CPR aid devices (with and 
without feedback) can be adequately mitigated by the special controls 
as outlined in tables 1 to 3.

[[Page 33132]]



    Table 1--Risks to Health and Mitigation Measures for ECC Devices
------------------------------------------------------------------------
           Identified risk                    Mitigation measures
------------------------------------------------------------------------
Cardiac arrhythmias or electrical       Electrical Safety and
 shock.                                 Electromagnetic Compatibility
                                        Testing (e.g., ISO 60601-1 and
                                        ISO 60601-1-2).
                                        Labeling.
Tissue/organ damage..................   Performance testing,
                                        including bench testing.
                                        Software verification/
                                        validation/hazards analysis.
                                        Human factors testing
                                        and analysis.
                                        Labeling.
                                        Training.
Bone breakage (ribs, sternum)........   Performance testing,
                                        including bench testing.
                                        Software verification/
                                        validation/hazards analysis.
                                        Human factors testing
                                        and analysis.
                                        Labeling.
                                        Training.
Inadequate blood flow................   Performance testing,
                                        including bench testing.
                                        Software verification/
                                        validation/hazards analysis.
                                        Human factors testing
                                        and analysis.
                                        Labeling.
                                        Training.
Adverse skin reactions...............   Assessment/use of
                                        biocompatible materials.
------------------------------------------------------------------------


  Table 2--Risks to Health and Mitigation Measures for CPR Aid Devices
                              With Feedback
------------------------------------------------------------------------
           Identified risk                    Mitigation measures
------------------------------------------------------------------------
Suboptimal CPR delivery..............   Performance testing.
                                        For devices that
                                        incorporate electrical
                                        components, electrical safety
                                        and electromagnetic
                                        compatibility testing;
                                        For devices containing
                                        software, software verification,
                                        validation, and hazard;
                                        Human factors testing
                                        and analysis;
                                        Labeling must include
                                        clinical training, if needed.
Adverse skin reactions...............   Assessment/use of
                                        biocompatible materials.
------------------------------------------------------------------------


  Table 3--Risks to Health and Mitigation Measures for CPR Aid Devices
                            Without Feedback
------------------------------------------------------------------------
           Identified risk                    Mitigation measures
------------------------------------------------------------------------
Suboptimal CPR delivery..............   General Controls
                                       [cir] Labeling: Intended for use
                                        by professionally trained
                                        rescuers.
                                       [cir] Quality system regulation
                                        requirements, including design
                                        controls for devices that
                                        include software.
Adverse skin reactions...............   Assessment/use of
                                        biocompatible materials.\1\
------------------------------------------------------------------------
\1\ Given the benefit/risk profile, this risk can be adequately
  mitigated in this patient population by general controls.

IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings, 
in part, as published in the preamble to the proposed order (78 FR 
1162, January 8, 2013). FDA has made revisions in this final order in 
response to the comments received (see section II) and the 
deliberations of the Panel (see section III). As published in the 
proposed order, FDA is issuing this final order to reclassify ECC 
(under FDA product code DRM) from class III to class II and establish 
special controls by revising part 870 (21 CFR 870.5200). The 
identification for 21 CFR 870.5200 has been revised to specify that 
these are prescription devices and to clarify that these devices are 
reclassified only for adjunctive use by changing the identification to 
read ``. . . when effective manual CPR is not possible (e.g., during 
patient transport or extended CPR when fatigue may prohibit the 
delivery of effective/consistent compressions to the victim, or when 
insufficient EMS personnel are available to provide effective CPR).''
    For clarity, in this final order, FDA has created a separate 
classification regulation for CPR aid devices, 21 CFR 870.5210, instead 
of continuing to include these devices within the ECC classification 
regulation as was originally proposed and how the devices were 
originally cleared for marketing authorization. In making this 
decision, FDA considered a comment received on the proposed order that 
supported creating a separate identity for CPR aid devices because 
their intended uses and technological characteristics are distinct from 
ECC devices. Additionally, the creation of a separate classification 
regulation for CPR aid devices allows for further clarification of the 
exemption from the premarket notification procedures for certain 
devices. The new classification regulation for CPR aid devices in this 
final order includes the same special controls that were included in 
the 2013 proposed order; however, FDA has divided the CPR aid 
identification into devices that provide feedback to the rescuer and 
those that do not. Devices that do not provide feedback have been 
reclassified into class I, based upon the ability of general controls 
to sufficiently mitigate the risks to health and demonstrate a 
reasonable assurance of safety and effectiveness of these devices, 
whereas devices that do provide feedback are reclassified into class II 
as originally proposed, based upon the additional need for special 
controls, in

[[Page 33133]]

combination with general controls, to sufficiently mitigate the risks 
to health and demonstrate a reasonable assurance of safety and 
effectiveness of these devices.
    In response to the input of the Panel, FDA also made refinements to 
the proposed special controls. FDA added special controls requirements 
for automated ECC devices, including performance testing of the time 
necessary to deploy the device and additional labeling requirements 
that include: (1) Prominent display of adjunctive-only use of the 
device, (2) labeling of the expected deployment time, and (3) labeling 
limitations on patient population/size (e.g., adult, pediatric, infant) 
for use of the device. FDA also added the labeling requirement 
regarding limitations on patient population/size for the CPR aid 
devices and modified the language for the human factors special 
controls to read: ``Human factors testing and analysis must validate 
that the device design and labeling are sufficient for the intended 
user.''
    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 ECC devices, and therefore, this device type is not 
exempt from premarket notification requirements. However, FDA has 
determined that premarket notification is not necessary for some class 
II CPR aid devices. FDA modified the criteria for exemption from 
section 510(k) for CPR aid devices with feedback from the originally 
proposed ``if it is a prescription use device that provides feedback to 
the rescuer consistent with the current AHA Guidelines for 
Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science 
in compliance'' to ``if it does not contain software (e.g., is 
mechanical or electro-mechanical).''
    Following the effective date of this final order, firms marketing 
an ECC device or CPR aid device with feedback must comply with the 
applicable mitigation measures set forth in the codified special 
controls (see section VII). Manufacturers of ECC devices and CPR aid 
devices with feedback that have not been legally marketed prior to the 
effective date of the final order, or models (if any) that have been 
legally marketed but are required to submit a new 510(k) under 21 CFR 
807.81(a)(3) because the device is about to be significantly changed or 
modified, must obtain 510(k) clearance and demonstrate compliance with 
the special controls included in the final order, before marketing the 
new or changed device.

V. Analysis of 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.

VI. Paperwork Reduction Act of 1995

    This final order refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 814, subpart B, are approved under OMB control number 0910-0231; 
the collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120; and the collections of 
information under 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

VII. 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. Although 
section 513(e) as amended requires FDA to issue final orders rather 
than regulations, FDASIA also provides for FDA to revoke previously 
issued regulations by order. FDA will continue to codify 
classifications and reclassifications in the Code of Federal 
Regulations (CFR). 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 21 CFR 870.5200 related to the classification of 
ECCs as class III devices and codifying the reclassification of ECCs 
into class II (special controls) and also codifying in 21 CFR 870.5210 
the reclassification of CPR Aid devices with feedback into class II 
(special controls) and CPR Aid devices without feedback into class I 
(general controls).

VIII. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Field, J.M., M.F. Hazinski, M.R. Sayre, et al., ``Part 1: 
Executive Summary: 2010 American Heart Association Guidelines for 
Cardiopulmonary Resuscitation and Emergency Cardiovascular Care,'' 
Circulation, 122:S640-S656, 2010, available at: https://circ.ahajournals.org/content/122/18_suppl_3.toc.
2. The Circulatory System Devices Panel of the Medical Devices 
Advisory Committee Meeting (September 11-12, 2013) transcript, 
executive summary, and other meeting materials are available on 
FDA's Web site at https://www.fda.gov/advisorycommittees/calendar/ucm364767.htm.

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.  870.5200 to read as follows:


Sec.  870.5200  External cardiac compressor.

    (a) Identification. An external cardiac compressor is an externally 
applied prescription device that is electrically, pneumatically, or 
manually powered and is used to compress the chest periodically in the 
region of the heart to provide blood flow during cardiac arrest. 
External cardiac compressor devices are used as an adjunct to manual 
cardiopulmonary resuscitation (CPR) when effective manual CPR is not 
possible (e.g., during patient transport or extended CPR when fatigue 
may prohibit the delivery of effective/consistent compressions to the 
victim, or when insufficient EMS personnel are available to provide 
effective CPR).

[[Page 33134]]

    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Nonclinical performance testing under simulated physiological 
conditions must demonstrate the reliability of the delivery of specific 
compression depth and rate over the intended duration of use.
    (2) Labeling must include the following:
    (i) The clinical training necessary for the safe use of this 
device;
    (ii) Adjunctive use only indication prominently displayed on labels 
physically placed on the device and in any device manuals or other 
labeling;
    (iii) Information on the patient population for which the device 
has been demonstrated to be effective (including patient size and/or 
age limitations, e.g., adult, pediatric and/or infant); and
    (iv) Information on the time necessary to deploy the device as 
demonstrated in the performance testing.
    (3) For devices that incorporate electrical components, appropriate 
analysis and testing must demonstrate that the device is electrically 
safe and electromagnetically compatible in its intended use 
environment.
    (4) Human factors testing and analysis must validate that the 
device design and labeling are sufficient for effective use by the 
intended user, including an evaluation for the time necessary to deploy 
the device.
    (5) For devices containing software, software verification, 
validation, and hazard analysis must be performed.
    (6) Components of the device that come into human contact must be 
demonstrated to be biocompatible.

0
3. Add Sec.  870.5210 to subpart F to read as follows:


Sec.  870.5210  Cardiopulmonary resuscitation (CPR) aid.

    (a) CPR aid without feedback--(1) Identification. A CPR aid without 
feedback is a device that performs a simple function such as proper 
hand placement and/or simple prompting for rate and/or timing of 
compressions/breathing for the professionally trained rescuer, but 
offers no feedback related to the quality of the CPR being provided. 
These devices are intended for use by persons professionally trained in 
CPR to assure proper use and the delivery of optimal CPR to the victim.
    (2) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  870.9.
    (b) CPR aid with feedback--(1) Identification. A CPR Aid device 
with feedback is a device that provides real-time feedback to the 
rescuer regarding the quality of CPR being delivered to the victim, and 
provides either audio and/or visual information to encourage the 
rescuer to continue the consistent application of effective manual CPR 
in accordance with current accepted CPR guidelines (to include, but not 
be limited to, parameters such as compression rate, compression depth, 
ventilation, recoil, instruction for one or multiple rescuers, etc.). 
These devices may also perform a coaching function to aid rescuers in 
the sequence of steps necessary to perform effective CPR on a victim.
    (2) Classification. Class II (special controls). The special 
controls for this device are:
    (i) Nonclinical performance testing under simulated physiological 
or use conditions must demonstrate the accuracy and reliability of the 
feedback to the user on specific compression rate, depth and/or 
respiration over the intended duration, and environment of use.
    (ii) Labeling must include the clinical training, if needed, for 
the safe use of this device and information on the patient population 
for which the device has been demonstrated to be effective (including 
patient size and/or age limitations, e.g., adult, pediatric and/or 
infant).
    (iii) For devices that incorporate electrical components, 
appropriate analysis and testing must demonstrate that the device is 
electrically safe and electromagnetically compatible in its intended 
use environment.
    (iv) For devices containing software, software verification, 
validation, and hazard analysis must be performed.
    (v) Components of the device that come into human contact must be 
demonstrated to be biocompatible.
    (vi) Human factors testing and analysis must validate that the 
device design and labeling are sufficient for effective use by the 
intended user.
    (3) Premarket notification. The CPR Aid with feedback device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter if it does not contain software (e.g., is 
mechanical or electro-mechanical) and is in compliance with the special 
controls under paragraph (b)(2) of this section, subject to the 
limitations of exemptions in Sec.  870.9.

    Dated: May 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12333 Filed 5-24-16; 8:45 am]
BILLING CODE 4164-01-P