[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Rules and Regulations]
[Pages 22525-22530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0650]


Cardiovascular Devices; Reclassification of External Pacemaker 
Pulse Generator Devices; Reclassification of Pacing System Analyzers

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 pacemaker pulse generator (EPPG) devices, 
which are currently preamendments class III devices (regulated under 
product code

[[Page 22526]]

DTE), into class II (special controls) and to reclassify pacing system 
analyzers (PSAs) into class II (special controls) based on new 
information and subject to premarket notification. This final order 
also creates a separate classification regulation for PSAs and places 
single and dual chamber PSAs, which are currently classified with EPPG 
devices, and triple chamber PSAs (TCPSAs), which are currently 
postamendments class III devices, into that new classification 
regulation.

DATES: This order is effective April 18, 2016.

FOR FURTHER INFORMATION CONTACT: Hina Pinto, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1652, Silver Spring, MD 20993, 301-796-6351, 
[email protected].

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, 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) establishes 
three categories (classes) of devices, reflecting the regulatory 
controls needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513(d) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
May 28, 1976 (generally referred to as preamendments devices), are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    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.
    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 postamendments device that has been initially classified in class 
III under section 513(f)(1) of the FD&C Act may be reclassified into 
class I or class II under section 513(f)(3) of the FD&C Act. Section 
513(f)(3) of the FD&C Act provides that FDA acting by order can 
reclassify the device into class I or class II on its own initiative, 
or in response to a petition from the manufacturer or importer of the 
device. To change the classification of the device, the proposed new 
class must have sufficient regulatory controls to provide reasonable 
assurance of the safety and effectiveness of the device for its 
intended use.
    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 under that section 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) 
of the FD&C Act or an interested person may petition FDA to reclassify 
an eligible device type. 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 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. 
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers Assoc. 
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 
reclassification 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 order to reclassify a device under that section. 
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 EPPG and PSA devices in the Federal Register of September 
15, 2014 (79 FR 54927) (the ``proposed order''). On September 11, 2013, 
FDA held a meeting of a device classification panel described in 
section 513(b) to discuss reclassification of EPPG and PSA devices (the 
``2013 Panel''). FDA

[[Page 22527]]

has also received and considered comments on the proposed order as 
discussed in section III. Therefore, FDA has satisfied the requirements 
for issuing a final order under section 513(e)(1) of the FD&C Act.

II. Regulatory History of the Devices

    As noted in the proposed order, on March 9, 1979, the Agency 
published a proposed rule for the classification of EPPG devices into 
class III (44 FR 13284). FDA subsequently published a final rule 
classifying EPPG devices into class III under Sec.  [thinsp]870.3600 
(21 CFR 870.3600) after receiving no comments on the March 9, 1979, 
proposed rule (45 FR 7904, February 5, 1980). In 1987, FDA published a 
final rule to codify language clarifying that no effective date had 
been established for the requirement for premarket approval for EPPG 
devices (52 FR 17732, May 11, 1987). In 2009, FDA published an order 
(the ``515(i) Order'') requiring manufacturers of remaining class III 
devices for which regulations requiring PMAs had not been issued, 
including EPPGs, to submit a summary of information concerning those 
devices by August 7, 2009 (74 FR 16214, April 9, 2009). On October 17, 
2011, FDA published a proposed rule proposing the reclassification of 
EPPG devices from class III to class II (76 FR 64224), which the Agency 
subsequently withdrew on September 15, 2014 (79 FR 54927). FDA withdrew 
the proposed rule in response to the new process for reclassifications 
under section 513(e) of the FD&C Act, as amended by FDASIA, and new 
information, including new information discussed during the 2013 Panel 
meeting.
    Single and dual chamber PSAs have historically been classified with 
EPPG devices. Single and dual chamber PSAs combine the functionality of 
a single or dual chamber EPPG, which is currently a class III device, 
and the functionality of a pacemaker electrode function tester, which 
is regulated as a class II device under Sec.  870.3720 (21 CFR 
870.3720). Single and dual chamber PSA devices have been found 
substantially equivalent to EPPG devices through the 510(k) process. 
TCPSA devices have not been determined to be substantially equivalent 
to a predicate device through the 510(k) process and, because TCPSAs 
were not on the market before May 28, 1976, TCPSAs have been reviewed 
through the PMA process as postamendments class III devices. This order 
creates a new classification regulation for single, dual, and triple 
chamber PSA devices, which combine the functionality of an EPPG and the 
functionality of a pacemaker electrode function tester.
    As discussed in the proposed order, FDA considered the available 
information on these devices (EPPG and PSA devices) and concluded that 
reclassifying these devices to class II, subject to the identified 
special controls, would provide reasonable assurance of their safety 
and effectiveness. As required by section 513(e)(1) of the FD&C Act, 
FDA convened a meeting of a device classification panel described in 
section 513(b) of the FD&C Act to discuss whether EPPG and PSA devices 
should be reclassified or remain in class III on September 11, 2013 (78 
FR 49272). The reclassification of EPPG and PSA devices was supported 
by the 2013 Panel. The 2013 Panel recommended that EPPG devices 
(including single and dual chamber PSAs) be reclassified to class II 
with special controls when intended for cardiac rate control or 
prophylactic arrhythmia prevention. In addition, the 2013 Panel agreed 
that EPPG devices are life-supporting and, per Sec.  860.93 (21 CFR 
860.93), explained that its rationale for recommending that EPPG 
devices be reclassified to class II was based on the proposed special 
controls FDA presented, which the 2013 Panel believed were adequate 
(along with general controls) to mitigate the risks of the device.
    The 2013 Panel also recommended that TCPSA devices be reclassified 
to class II with special controls when intended for use during the 
pulse generator implant procedure. The 2013 Panel acknowledged that 
TCPSA devices are life-supporting devices and provided the following 
rationale per Sec.  860.93 for recommending that TCPSA devices be 
reclassified to class II: (1) These devices are used only during the 
implant procedure where backup monitoring is continuous, hazards can be 
recognized and treated immediately, and where there is a reasonable 
expectation that users are adequately trained; (2) these devices are 
not intended to provide the long-term hemodynamic benefit of 
biventricular pacing or cardiac resynchronization therapy; and (3) the 
recommended special controls will mitigate the health risks associated 
with the device. The 2013 Panel transcript and other meeting materials 
are available on FDA's Web site (Ref. 1). Since the 2013 Panel meeting, 
FDA has not become aware of new information that would provide a basis 
for a device classification panel to make a different recommendation or 
different findings.

III. Public Comments in Response to the Proposed Order

    In response to the September 15, 2014, proposed order to reclassify 
EPPG and PSA devices (79 FR 54927), FDA received two comments. FDA 
previously received three sets of comments on the October 17, 2011, 
proposed rule to reclassify EPPG devices that was subsequently 
withdrawn (79 FR 54927). The Agency has considered all of these 
comments in drafting this final order.
    The comments and FDA's responses to the comments are summarized in 
this section. Certain comments are grouped together under a single 
number because the subject matter of the comments is similar. The 
number assigned to each comment is purely for organizational purposes 
and does not signify the comment's value or importance or the order in 
which it was submitted.
    (Comment 1) Four comments suggested that EPPG devices are life-
sustaining and should be subject to premarket approval to provide 
better assurance of safety and effectiveness; as such, the comments 
asserted that EPPG devices should remain in class III. Further, one 
comment indicated that the proposed special controls are not sufficient 
to mitigate the risks associated with EPPG devices. Three other 
comments also discussed the risks associated with these devices and the 
need for adequate mitigation through premarket approval.
    (Response 1) These comments were considered by FDA in drafting this 
final order. Per 21 CFR 860.3(c)(3), a device is in class III if two 
conditions are met: (1) Insufficient information exists to determine 
that general controls are sufficient to provide reasonable assurance of 
its safety and effectiveness or that application of special controls 
described in 21 CFR 860.3(c)(2) would provide such assurance, and (2) 
the device is life-supporting or life-sustaining, or for a use which is 
of substantial importance in preventing impairment of human health, or 
if the device presents a potential unreasonable risk of illness or 
injury. FDA has concluded that for EPPG devices, special controls will 
provide reasonable assurance of safety and effectiveness to 
appropriately mitigate risks to health. Therefore, these life-
supporting devices can be reclassified into class II. As discussed in 
section II, the 2013 Panel agreed with FDA's recommendation of class II 
for EPPG and TCPSA devices.
    EPPG devices are therapeutic devices designed to be used 
temporarily and in a controlled clinical setting. The expected presence 
of clinical support

[[Page 22528]]

and physician monitoring mitigates many potential complications. 
Specifically, EPPG devices are used exclusively in hospital 
environments with the patients supervised by qualified medical 
personnel. The environment of care for EPPG devices includes 
resuscitation equipment, hospital level monitoring of heart rhythm, and 
patient vital status by other devices with alarm functions. The special 
controls require labeling for EPPG devices to ``clearly state that 
these devices are intended for use in a hospital environment and under 
the supervision of a clinician trained in their use.'' Further, the 
non-clinical performance testing and labeling special controls 
appropriately mitigate the risks for EPPG devices by helping to ensure 
adequate device performance/pacing, as well as proper maintenance of 
the device.
    (Comment 2) Three comments referenced the number of medical device 
reports (MDRs) associated with EPPG devices and suggested that MDR data 
support keeping EPPG devices in class III. Two of those comments also 
discussed the number of MDR reports for malfunctions associated with 
EPPG devices and suggested that this shows the performance standards 
that have been developed and used to support EPPG marketing 
applications are insufficient to provide reasonable assurance of safety 
and effectiveness.
    (Response 2) Increased premarket regulatory requirements cannot be 
assumed to result in fewer MDRs, nor are MDRs necessarily an indicator 
of poor device performance. FDA performed multiple analyses of MDRs for 
EPPG devices in the Manufacturer and User Facility Device Experience 
(MAUDE) database. The Agency's analysis of the available data shows 
that over 85 percent of reports had either no patient involvement or no 
known consequences to the patient. These types of malfunction reports 
were generally discovered during routine servicing, which may be 
anticipated for reusable electrical devices. FDA's MDR analyses were 
conducted multiple times during the reclassification process and showed 
trends of increased reporting, but with an associated sharp decline in 
the relative number of death and injury reports over the last several 
years (i.e., the increased reporting was largely for device 
malfunctions). FDA believes these trends are indicative of tighter 
adherence to MDR requirements and a related change in reporting 
practices rather than a change in device performance. FDA's detailed 
review of MDRs for EPPG devices also did not suggest design or 
functional issues that would be decreased by requiring premarket 
approval for EPPG devices.
    FDA also reviewed device recalls for EPPGs over the past 15 years 
and did not find evidence indicating the need for class III premarket 
approval regulation of these devices. FDA presented its analysis of MDR 
and recall data to the 2013 Panel that ultimately recommended 
reclassification of EPPG devices from class III to class II (special 
controls). The 2013 Panel identified no new or different risks for EPPG 
devices based on that information. Therefore, FDA believes that the 
identified special controls provide adequate mitigation of the health 
risks posed by the EPPG device.
    (Comment 3) One comment suggested that EPPG devices remain in class 
III and require PMAs because FDA failed to identify new information on 
which to base the reclassification recommendation, specifically noting: 
(1) Performance standards developed in support of PMAs are not publicly 
available, and (2) FDA used information submitted in response to the 
515(i) Order that was not publicly available in the Agency's analysis 
of risks to health for EPPG devices.
    (Response 3) FDA's presentation to the 2013 Panel included a 
summary of the available safety and effectiveness information for EPPG 
devices, including FDA's analysis of adverse event reports from FDA's 
MAUDE database and available literature. The 2013 Panel agreed with 
FDA's conclusion that the available scientific evidence is adequate to 
support reasonable assurance of the safety and effectiveness of EPPG 
devices and to reclassify EPPG devices to class II. While the 2013 
Panel agreed with the identified risks to health presented at the 
September 11, 2013, meeting, it recommended that FDA consider rewording 
some of the language for clarity and also to ensure that certain 
hazards, such as asynchronous pacing and arrhythmia induction, are 
included in the risks to health. FDA agreed with the 2013 Panel's 
recommendations and modified the risks to health accordingly as 
outlined in section V of the 2014 proposed order. The Agency identified 
in the proposed order special controls, including non-clinical 
performance testing data and labeling that, together with general 
controls (including prescription use), would provide reasonable 
assurance of the safety and effectiveness of EPPG devices. Since the 
2013 Panel, FDA has not become aware of new information that would 
provide a basis for a different recommendation or finding for these 
devices.
    Information submitted in response to the 2009 515(i) Order that FDA 
used in its reclassification determination was incorporated in what the 
Agency presented to the 2013 Panel (see Ref. 1). In addition, that 
information was listed in the September 15, 2014, proposed order and is 
publicly available through other sources. The information presented to 
the 2013 Panel and discussed in the 2014 proposed order also identified 
and provided information regarding the two recognized consensus 
standards that address various aspects of design and performance of 
EPPG devices (IEC 60601-1 and IEC 60601-2-31). The information provided 
by these consensus standards is particularly important as design 
control measures and aided in forming part of the basis for FDA's 
reclassification determination. Therefore, the information that forms 
the basis for FDA's reclassification determination has been made 
publicly available.
    (Comment 4) One comment suggested that PSA devices remain in class 
III because the special controls rely heavily on labeling to mitigate 
risks, and expressed doubt that labeling would be sufficient to protect 
the health of patients.
    (Response 4) It should be noted that labeling is not the only 
mitigation that is proposed to reasonably assure safety and 
effectiveness of PSAs. Further, neither FDA nor the 2013 Panel believed 
that clinical performance testing was necessary to provide reasonable 
assurance of safety or effectiveness. The environment of care for PSAs 
is limited to the surgical implant suite, which must have backup 
pacing, defibrillation and resuscitation equipment, and capabilities 
including intensive care level monitoring of heart rhythm and patient 
vital signs. Therefore, FDA believes that the non-clinical performance 
testing and labeling special controls, in addition to general controls, 
can be established to mitigate the identified risks and provide 
reasonable assurance of the safety and effectiveness of PSA devices 
when indicated for use during the implant procedure of pacemakers and 
defibrillators for the evaluation of the placement and integrity of 
pacing leads to determine the appropriate pacing parameters for the 
implanted device. Furthermore, the 2013 Panel agreed that the special 
controls would mitigate the health risks associated with the PSA 
devices.

IV. The Final Order

    Based on the information discussed in the preamble to the proposed 
order (79 FR 54927, September 15, 2014), the comments received, a 
review of the

[[Page 22529]]

MAUDE database and recall data, a review of current scientific 
literature, and the 2013 Panel deliberations (see the 2013 Panel 
transcript (Ref. 1)), FDA concludes that special controls, in 
conjunction with general controls, will provide reasonable assurance of 
the safety and effectiveness of EPPG and PSA devices. Under sections 
513(e) and 513(f) of the FD&C Act, FDA is adopting its findings, as 
published in the preamble to the proposed order. FDA is issuing this 
final order to reclassify EPPG devices from class III to class II 
(special controls), as well as to create a separate classification 
regulation for PSA devices and reclassify PSA devices into class II 
(special controls). As noted in the proposed order, FDA is also making 
a slight modification to the identification for EPPG devices in Sec.  
[thinsp]870.3600 to clarify that these are prescription devices.
    Following the effective date of this final order, firms marketing 
an EPPG or PSA device must comply with the applicable mitigation 
measures set forth in the codified special controls. Manufacturers of 
EPPG or PSA devices that have not been legally marketed prior to the 
effective date of this final order, or models (if any) that have been 
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 this final order, before marketing the 
new or changed device.
    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 device. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of safety and 
effectiveness of EPPG and PSA devices for their intended uses, and 
therefore, these device types are not exempt from premarket 
notification requirements.

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 previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 814 have been 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 
promulgated 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, pursuant to 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.  [thinsp]870.3600 related to the 
classification of EPPG devices as class III devices, and codifying the 
reclassification of EPPG and PSA devices into class II (special 
controls).

VIII. Reference

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

    1. The panel transcript and other meeting materials for the 
September 11, 2013, Circulatory System Devices Panel are available 
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.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. Section 870.3600 is revised to read as follows:


Sec.  870.3600  External pacemaker pulse generator.

    (a) Identification. An external pacemaker pulse generator (EPPG) is 
a prescription device that has a power supply and electronic circuits 
that produce a periodic electrical pulse to stimulate the heart. This 
device, which is used outside the body, is used as a temporary 
substitute for the heart's intrinsic pacing system until a permanent 
pacemaker can be implanted, or to control irregular heartbeats in 
patients following cardiac surgery or a myocardial infarction. The 
device may have adjustments for impulse strength, duration, R-wave 
sensitivity, and other pacing variables.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must validate electromagnetic 
compatibility (EMC) within a hospital environment.
    (2) Electrical bench testing must demonstrate device safety during 
intended use. This must include testing with the specific power source 
(i.e., battery power, AC mains connections, or both).
    (3) Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
    (i) Testing must demonstrate the accuracy of monitoring functions, 
alarms, measurement features, therapeutic features, and all adjustable 
or programmable parameters as identified in labeling;
    (ii) Mechanical bench testing of material strength must demonstrate 
that the device and connection cables will withstand forces or 
conditions encountered during use;
    (iii) Simulated use analysis/testing must demonstrate adequate user 
interface for adjustable parameters, performance of alarms, display 
screens, interface with external devices (e.g. data storage, printing), 
and indicator(s) functionality under intended use conditions; and
    (iv) Methods and instructions for cleaning the pulse generator and 
connection cables must be validated.
    (4) Appropriate software verification, validation, and hazard 
analysis must be performed.

[[Page 22530]]

    (5) Labeling must include the following:
    (i) The labeling must clearly state that these devices are intended 
for use in a hospital environment and under the supervision of a 
clinician trained in their use;
    (ii) Connector terminals should be clearly, unambiguously marked on 
the outside of the EPPG device. The markings should identify positive 
(+) and negative (-) polarities. Dual chamber devices should clearly 
identify atrial and ventricular terminals;
    (iii) The labeling must list all pacing modes available in the 
device;
    (iv) Labeling must include a detailed description of any special 
capabilities (e.g., overdrive pacing or automatic mode switching); and
    (v) Appropriate electromagnetic compatibility information must be 
included.

0
3. In Subpart D, add Sec.  870.3605 to read as follows:


Sec.  870.3605  Pacing system analyzer.

    (a) Identification. A pacing system analyzer (PSA) is a 
prescription device that combines the functionality of a pacemaker 
electrode function tester (Sec.  870.3720) and an external pacemaker 
pulse generator (EPPG) (Sec.  870.3600). It is connected to a pacemaker 
lead and uses a power supply and electronic circuits to supply an 
accurately calibrated, variable pacing pulse for measuring the 
patient's pacing threshold and intracardiac R-wave potential. A PSA may 
be a single, dual, or triple chamber system and can simultaneously 
deliver pacing therapy while testing one or more implanted pacing 
leads.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must validate electromagnetic 
compatibility (EMC) within a hospital environment.
    (2) Electrical bench testing must demonstrate device safety during 
intended use. This must include testing with the specific power source 
(i.e., battery power, AC mains connections, or both).
    (3) Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
    (i) Testing must demonstrate the accuracy of monitoring functions, 
alarms, measurement features, therapeutic features, and all adjustable 
or programmable parameters as identified in labeling;
    (ii) Mechanical bench testing of material strength must demonstrate 
that the device and connection cables will withstand forces or 
conditions encountered during use;
    (iii) Simulated use analysis/testing must demonstrate adequate user 
interface for adjustable parameters, performance of alarms, display 
screens, interface with external devices (e.g. data storage, printing), 
and indicator(s) functionality under intended use conditions; and
    (iv) Methods and instructions for cleaning the pulse generator and 
connection cables must be validated.
    (4) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (5) Labeling must include the following:
    (i) The labeling must clearly state that these devices are intended 
for use in a hospital environment and under the supervision of a 
clinician trained in their use;
    (ii) Connector terminals should be clearly, unambiguously marked on 
the outside of the PSA. The markings should identify positive (+) and 
negative (-) polarities. Dual chamber devices should clearly identify 
atrial and ventricular terminals. Triple chamber devices should clearly 
identify atrial, right ventricular, and left ventricular terminals;
    (iii) The labeling must list all pacing modes available in the 
device;
    (iv) Labeling must include a detailed description of any special 
capabilities (e.g., overdrive pacing or automatic mode switching);
    (v) Labeling must limit the use of external pacing to the implant 
procedure; and
    (vi) Appropriate electromagnetic compatibility information must be 
included.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08898 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P