[Federal Register Volume 80, Number 22 (Tuesday, February 3, 2015)]
[Rules and Regulations]
[Pages 5674-5683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2013-N-0234]


Effective Date of Requirement for Premarket Approval for 
Automated External Defibrillator Systems; Republication

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; republication.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
republishing in its entirety a final order entitled ``Effective Date of 
Requirement for Premarket Approval for Automated External 
Defibrillator'' that published in the Federal Register on January 29, 
2015 (80 FR 4783). FDA is republishing to correct an inadvertent 
omission of a comment regarding adverse tissue reaction as a risk to 
health and the Agency's response to that comment. The final order 
requires the filing of premarket approval applications (PMA) for 
automated external defibrillator (AED) systems, which consist of an AED 
and those AED accessories necessary for the AED to detect and interpret 
an electrocardiogram and deliver an electrical shock (e.g., pad 
electrodes, batteries, adapters, and hardware keys for pediatric use).

DATES: This order is effective on February 3, 2015.

FOR FURTHER INFORMATION CONTACT: Linda Ricci, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 1314, 
Silver Spring, MD 20993, 301-796-6325, [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

[[Page 5675]]

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); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as ``postamendments devices'') are 
automatically classified by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval unless, and until, the device is 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the FD&C Act, to a predicate device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR part 807).
    A preamendments device that has been classified into class III and 
devices found substantially equivalent by means of premarket 
notification (510(k)) procedures to such a preamendments device or to a 
device within that type (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. Section 
515(b)(1) of the FD&C Act directs FDA to issue an order requiring 
premarket approval for a preamendments class III device.
    Although, under the FD&C Act, the manufacturer of a class III 
preamendments device may respond to the call for PMAs by filing a PMA 
or a notice of completion of a 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 (126 
Stat. 1056) amended section 513(e) of the FD&C Act, changing the 
mechanism for reclassifying a device from rulemaking to an 
administrative order. Section 608(b) of FDASIA amended section 515(b) 
of the FD&C Act changing the mechanism for requiring premarket approval 
for a preamendments class III device from rulemaking to an 
administrative order.
    Section 515(b)(1) of the FD&C Act sets forth the process for 
issuing a final order. Specifically, prior to the issuance of a final 
order requiring premarket approval for a preamendments class III 
device, the following must occur: (1) Publication of a proposed order 
in the Federal Register; (2) a meeting of a device classification panel 
described in section 513(b) of the FD&C Act; and (3) consideration of 
comments from all affected stakeholders, including patients, payers, 
and providers.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after 
the close of the comment period on the proposed order, consideration of 
any comments received, and a meeting of a device classification panel 
described in section 513(b) of the FD&C Act, issue a final order to 
require premarket approval or publish a document terminating the 
proceeding together with the reasons for such termination.
    A preamendments class III device may be commercially distributed 
without a PMA until 90 days after FDA issues a final order (a final 
rule issued under section 515(b) of the FD&C Act prior to the enactment 
of FDASIA is considered to be a final order for purposes of section 
501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval 
for the device, or 30 months after final classification of the device 
under section 513 of the FD&C Act, whichever is later. For AED systems, 
the later of these two time periods is the 90-day period. Therefore, 
section 501(f)(2)(B) of the FD&C Act requires that a PMA for such 
devices be filed within 90 days of the effective date of a final order. 
However, for the reasons discussed below, FDA does not intend to 
enforce compliance with the 90-day deadline for PMA submissions for 
currently marketed AEDs and those AED accessories identified in Sec.  
870.5310(a) (21 CFR 870.5310(a)) (see further discussion in section V, 
``Implementation Strategy'').
    Also, a preamendments device subject to the order process under 
section 515(b) of the FD&C Act is not required to have an approved 
investigational device exemption (IDE) (see part 812 (21 CFR part 812)) 
contemporaneous with its interstate distribution until the date 
identified by FDA in the final order requiring the filing of a PMA for 
the device. At that time, an IDE is required only if a PMA has not been 
filed. If the manufacturer, importer, or other sponsor of the device 
submits an IDE application and FDA approves it, the device may be 
distributed for investigational use. If a PMA is not filed by the later 
of the two dates, and the device is not distributed for investigational 
use under an IDE, the device is deemed to be adulterated within the 
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure 
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if 
its distribution continues. Other enforcement actions include, but are 
not limited to, the following: Shipment of devices in interstate 
commerce 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. Regulatory History of This Device

    On January 25, 2011, the Circulatory System Devices Panel 
(``Panel'') recommended that AED systems be classified as class III 
devices and subject to premarket approval to provide reasonable 
assurance of the safety and effectiveness of the device (Ref. 1). The 
Panel recommended that AED systems be regulated as class III devices 
because, among other things, they are lifesaving devices. Furthermore, 
the problems identified in adverse events in the

[[Page 5676]]

medical device reporting systems and recalls related to AED systems 
indicated these devices require more regulatory oversight.
    FDA published a proposed order to require PMAs for AED systems in 
the Federal Register of March 25, 2013 (78 FR 17890). FDA is now 
requiring PMAs for AED systems, which include AED accessories necessary 
for the functionality of the AED (e.g., pad electrodes, batteries, 
adapters, and hardware keys for pediatric use) (``necessary AED 
accessories'') (see section IV, ``The Final Order'').
    FDA received and has considered comments on the AED systems 
proposed order as discussed in section III of this document.

III. Public Comments in Response to the Proposed Order

    In response to the March 25, 2013 (78 FR 17890) proposed order to 
maintain the class III classification and require premarket approval 
for AED systems, FDA received 66 comments and one petition for 
reclassification (see FDA-2013-N-0234-0002) (Ref. 2). The comments and 
the FDA's responses to the comments are summarized below. 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) Many comments indicated that AED systems have already 
been demonstrated to be safe and effective, and referenced literature 
and studies supporting the reliability of these devices and the value 
of AED systems in treating sudden cardiac arrest (SCA). The comments 
stated that PMAs and associated increased regulatory cost and review 
time is not warranted and would hinder innovation, increase device cost 
to consumers, and reduce availability of AED systems. The comments 
further stated that it is widely recognized that improvement in the 
survival rate from SCA is due in large part to widespread distribution 
of AED systems and expressed concern that requiring PMAs would limit 
availability of the devices.
    (Response 1) FDA agrees that many currently marketed AEDs have been 
demonstrated to be effective in clinical use and, when designed and 
manufactured appropriately, AEDs can be safe and effective. However, 
FDA believes that there is insufficient information to determine that 
general and special controls would provide a reasonable assurance of 
the safety and effectiveness of these devices, which are for a use in 
supporting or sustaining human life (see section 513(a)(1)(C) of the 
FD&C Act. Specifically, the postmarket information on AEDs supports 
increased regulatory review to ensure that device design and 
manufacturing practices provide a reasonable assurance of safety and 
effectiveness. FDA acknowledges that the PMA process may result in 
increased regulatory cost to manufacturers; however, FDA believes that 
device quality will improve, which will reduce costs associated with 
postmarket actions including recalls.
    FDA also agrees that continued efforts to make safe and effective 
AED systems available is in the interest of public health, but 
disagrees that this call for PMAs will limit device availability. FDA 
believes that many manufacturers of currently marketed AEDs already 
have, or can reasonably obtain, the necessary data to support a PMA, 
and hence expects AED distribution to continue to meet demand. Also, 
for the reasons discussed below, FDA does not intend to enforce 
compliance with the 90-day deadline for submission of PMAs for 
currently marketed AEDs and necessary AED accessories (for further 
discussion see section V, ``Implementation Strategy'').
    At the January 2011 Panel meeting, the Panel discussed the impact 
of FDA regulatory scrutiny on innovation. Various Panel members agreed 
that the appropriate focus should be on assuring reliability of AEDs 
and that there was no evidence presented to indicate that a call for 
PMAs would unduly hinder device innovation (Ref. 1). FDA notes that 
previous significant innovations for AED systems (e.g., new 
defibrillation waveforms) have been supported by clinical evidence in 
the 510(k) process and that under the PMA process this clinical 
evidence is not expected to significantly change. As was mentioned in 
the proposed order, FDA anticipates that many AED manufacturers already 
have sufficient clinical evidence to support a PMA.
    (Comment 2) Several comments noted that AED system failures are 
often the result of use error or improper maintenance (e.g., expired 
batteries/pads, periodic checks not performed, etc.) and not of system 
failure or malfunction. The comments stated that efforts should be 
devoted to ensuring appropriate public awareness, training 
(particularly for lay users), and maintenance to address these issues 
as opposed to increasing premarket regulatory review. One comment 
stated that the proposed order should not be finalized until all 
stakeholders, not only device manufacturers, are engaged in an 
integrated approach to increase the likelihood that AED systems will be 
available and functional when needed.
    (Response 2) FDA agrees that AED system training and maintenance 
are important to help ensure AED system availability and proper use and 
also believes manufacturers and users are in the best position to 
develop and implement training and maintenance materials. FDA supports 
ongoing discussions and efforts to improve training and maintenance, 
but disagrees that these activities should delay finalizing the 
requirement for PMAs for these devices. Although we recognize that 
there have been some medical device reports (MDRs) associated with use 
errors, the focus of FDA's review of MDRs and recalls of AED systems 
has been related to problems with the quality of these devices as 
related to device design and manufacture and FDA continues to believe 
that requiring PMAs is appropriate.
    (Comment 3) Several comments stated that special controls, 
including performance testing to industry standards, device labeling, 
guidance documents, human factors analysis and design, summary of field 
actions and mitigations to address Quality System (QS) concerns, risk 
management, and post-market surveillance were sufficient to regulate 
AED systems as class II devices under the existing 510(k) regulatory 
regime. One comment indicated that several of the regulatory controls 
identified by FDA as consistent with PMA requirements--such as pre-
market inspections, review of changes that could significantly affect 
the safety or effectiveness of the device, and postmarket 
surveillance--could also be conducted under the 510(k) regime. Other 
comments supported FDA's proposal to maintain the devices in class III 
and agreed that the manufacturing controls, premarket review 
requirements, and assessment of lay use are best managed under the PMA 
process.
    (Response 3) FDA disagrees that there is sufficient information to 
determine that general and special controls would provide a reasonable 
assurance of safety and effectiveness of these devices given safety 
concerns related to the manufacturing processes and design changes, 
problems which FDA considered in determining that PMAs are warranted 
(see section 513(a)(1)(C) of the FD&C Act. FDA does not generally 
conduct preclearance inspections under the 510(k) process because such 
information is not required in a 510(k) submission under the FD&C Act 
or FDA regulations.

[[Page 5677]]

Further, under section 513(f)(5) of the FD&C Act, FDA may not withhold 
a 510(k) because of a failure to comply with any provision of this Act 
unrelated to a substantial equivalence decision, including a finding 
that the facility in which the device is manufactured is not in 
compliance with good manufacturing requirements as set forth in 
regulations of the Secretary under section 520(f) (other than a finding 
that there is a substantial likelihood that the failure to comply with 
such regulations will potentially present a serious risk to human 
health). In contrast, under section 515(c)(1)(C) of the FD&C Act, a PMA 
must include a full description of the methods used in, and the 
facilities and controls used for, the manufacturing, processing, and 
when relevant, packing and installation of, such device. Moreover, many 
of the design and manufacturing changes that have led to AED system 
recalls were not required to be reported to FDA under the 510(k) 
process. If these changes had been reported prior to implementation, as 
would be required in the PMA regime, these recalls may have been 
avoided. FDA continues to believe that the necessary regulatory 
controls for AED systems are consistent with the PMA review process, 
and that the 510(k) process does not provide sufficient regulatory 
oversight for these devices.
    Similarly, FDA's oversight of postmarket changes to devices is very 
different in the 510(k) context as compared to the PMA context. Under 
Sec.  807.81, FDA requires 510(k)s for a change to a device only when 
the change could significantly affect the safety or effectiveness of 
the device, e.g., a significant change or modification in design, 
material, chemical composition, energy source, or manufacturing 
process. In contrast, under 21 CFR 814.39, FDA requires PMA supplements 
(including 30-day notices) for any change to a PMA-approved device that 
affects safety or effectiveness. These differences in authorities, 
among the other reasons discussed previously, warrant regulation of 
AEDs in class III.
    (Comment 4) A few comments indicated that existing AED and AED 
accessory manufacturers are already subject to the QS regulation (21 
CFR part 820) and manufacturing quality would not be measurably 
improved as a result of requiring PMAs. One comment noted that specific 
expectations under the QS regulation for design controls, purchasing 
controls, and other issues identified by FDA as problematic for AEDs 
could be addressed by special controls and other regulations, and AEDs 
could remain in class II. One comment further stated that such concerns 
could be managed via postmarket controls, which are available under the 
510(k) regime, such as submission of a summary of recent field actions 
and related design mitigations.
    (Response 4) FDA disagrees with the comments. FDA acknowledges that 
AED and AED accessory manufacturers are already subject to the QS 
regulation and that QS requirements result in rigorously designed and 
manufactured devices and resultant quality improvements. By requiring 
premarket review of QS processes as well as device changes for AEDs, 
FDA believes the PMA process will provide a reasonable assurance of 
safety and effectiveness (see Response 3).
    (Comment 5) One comment stated that certain AED accessories, 
specifically electrodes, cables, and adapters, are well-understood 
devices and that their classification into class III is not warranted. 
The comment stated that these accessories could be adequately regulated 
in class II with special controls, as is already the case when these 
accessories are used with manual defibrillators. The comment 
recommended special controls, including the following: performance 
testing, usability evaluation, labeling, biocompatibility, and 
readiness for use. Two comments stated that because AED accessories 
often have identical designs and the same intended use as accessories 
used with class II manual defibrillators, FDA should not perform 
duplicative reviews under both the 510(k) and PMA regimes and that PMA 
review should be required only when use of the accessory with an AED 
results in a change in intended use or design.
    (Response 5) Accessories necessary for an AED to detect and 
interpret an electrocardiogram and deliver an electrical shock (e.g., 
battery, pad electrode, adapter, and hardware keys for pediatric use) 
are necessary for AED system functionality. Failure of these necessary 
accessories leads to the same negative outcomes as a failure of the AED 
itself; e.g., an AED not ready for use because of a faulty battery is 
unable to detect heart rhythm abnormalities and/or deliver a 
defibrillation shock to a victim of SCA. FDA's review of adverse events 
and recalls has shown that problems with AED accessories have occurred 
during clinical use. As such, FDA continues to believe that the same 
regulatory oversight is warranted for certain critical accessories 
(i.e., batteries, pad electrodes, adapters, and hardware keys for 
pediatric use) as for the AEDs with which they are used. As discussed 
in the response to Comment 3, FDA does not believe that adequate 
regulatory controls are available under the 510(k) process, and hence 
PMAs are necessary to provide a reasonable assurance of safety and 
effectiveness.
    (Comment 6) Several comments questioned the validity of FDA's data 
regarding adverse events associated with AED failures. One comment 
noted that FDA provided no data in the proposed order on the frequency 
of adverse events or relationship of number of events to total 
distribution and use of AEDs. The comment requested additional 
information from FDA to support the validity of the MDR analysis 
presented at the 2011 Panel and relied upon to support the proposed 
order. A few comments presented alternate analyses of MDR data that 
suggested that MDRs for AEDs are not increasing. One comment presented 
an analysis that showed no statistically significant increase in the 
rate of adverse event reports over the time period of 2007 to 2011. Two 
comments stated that a majority of AED MDRs reported to FDA resulted 
from self-test errors--which are reported as malfunction MDRs because 
they could cause or contribute to a death or serious injury but do not 
represent device failures in clinical use. The comments contended that 
any analysis of MDRs should focus instead on actual use adverse events, 
which would represent a small subset of the overall MDRs. One comment 
stated that self-test related events are representative of an effective 
design risk mitigation strategy being employed for AEDs and that 
because AEDs are often in standby for a large percentage of time, self-
test detection of problems before use should not be included in the 
overall assessment of the benefit-risk profile for AEDs. Two comments 
requested further guidance from FDA on MDR reporting expectations for 
AEDs.
    (Response 6) Although FDA requires manufacturers to submit an MDR 
when their device may have caused or contributed to a death, serious 
injury, or in certain situations when their device has malfunctioned, 
FDA acknowledges that there are limitations on the review of MDR data, 
including the fact that FDA typically does not have complete 
information on the number of devices in distribution from which to 
calculate adverse events rates. These limitations were discussed at the 
2011 Panel meeting. FDA has previously stated that fatality statistics 
and injury statistics from MDRs should be considered in light of 
underreporting (58 FR 61952 at 61972, November 23, 1993). In addition, 
FDA notes that the evaluation of MDR data for AEDs was focused on 
manufacturing and design concerns and was not aimed at developing 
specific

[[Page 5678]]

failure rates. Moreover, FDA believes that the large number of devices 
in distribution and the life-saving nature of these devices combined 
with the steady rate of MDRs support a call for PMAs to help ensure 
that these devices are adequately designed and manufactured so that 
they are available when needed.
    FDA disagrees that evaluation of adverse events should focus only 
on those events that occur during clinical use. Although some 
distributed AEDs may seldom be used, this does not reduce the 
importance that they are safe and effective when needed. FDA 
acknowledges the importance of AED self-test features and recognizes 
that many self-test failures are not indicative of issues with overall 
device quality. FDA believes, however, that some self-test failures 
signal significant quality problems arising from device design or 
manufacturing issues and are appropriately considered as adverse events 
if recurrence of such failures could, for example, render the device 
unavailable for use when needed. FDA also recognizes that some MDRs may 
eventually be found to be the result of problems not associated with 
the device; however, this concern is applicable to all devices subject 
to adverse event reporting requirements and FDA does not believe such 
reports unduly influence overall reporting numbers.
    FDA also notes that our review of available information, as 
presented at the January 2011 Panel meeting, included data on voluntary 
corrections and removals (i.e., ``recalls'') of AEDs pursuant to 
section 519(g) of the FD&C Act (21 U.S.C. 360i(g)). Recalls are 
conducted ``(A) to reduce a risk to health posed by the device, or (B) 
to remedy a violation of this Act caused by the device which may 
present a risk to health,'' and as such may reflect safety concerns for 
AEDs (section 519(g)(1) of FD&C Act (21 U.S.C. 360i(g)(1)). Since the 
January 2011 Panel meeting, over 40 additional class I or class II 
recalls have been conducted by AED manufacturers and have impacted over 
2 million distributed AEDs (Ref. 3). The root cause of these recalls 
has been attributed to a variety of causes, with design controls, 
purchasing controls, and receiving acceptance activities being the most 
common. FDA continues to believe that the recall data reinforces the 
overall conclusion regarding the inadequacy of regulatory controls for 
AED systems under the 510(k) process.
    Additional guidance on MDR requirements for AEDs is beyond the 
scope of this document; however, FDA intends to continue efforts to 
clarify medical device reporting expectations and manufacturers who 
have questions regarding their reporting obligations should contact 
FDA.
    (Comment 7) FDA received a recommendation regarding including 
adverse tissue reaction as a risk to health when using AEDs, and a 
recommendation to require biocompatibility testing as a special control 
to mitigate the risk, specifically by ensuring the biocompatibility of 
the patient-contacting materials. The patient-contacting materials of 
the device may produce local adverse tissue effects, such as skin rash 
or irritation. Device materials that are not biocompatible may either 
directly or through the release of their material constituents produce 
adverse local or systemic effects. Although medical devices may have 
myriad biocompatibility issues, the biocompatibility concerns from AEDs 
are likely limited to skin reactions from contact with the materials 
from which the pad electrode is made.
    (Response 7) In the proposed order published in the Federal 
Register (78 FR 17890, March 25, 2013), FDA did not identify adverse 
tissue reaction as a risk associated with AEDs. However, FDA agrees 
that adverse tissue reaction is a risk to health for this device. For 
all of the reasons identified in the proposed order and this document, 
however, FDA believes that there is insufficient information to 
determine that general and special controls would provide a reasonable 
assurance of the safety and effectiveness of these devices. The risk of 
adverse tissue reactions, as well as the other risks posed by these 
devices, will be addressed during the premarket approval process of 
these devices.
    (Comment 8) Several comments responded to FDA's request for 
feedback regarding whether 15 months is sufficient to allow companies 
to collect information necessary to support submission of a PMA. Two 
comments stated that this issue was dependent on the data expected by 
FDA and that FDA should provide more guidance in this respect. One 
comment requested clarification on what clinical data is known to FDA 
that would support a PMA because it is critical that AED manufacturers 
understand the type and amount of data that will be required. One 
comment stated that it is unclear what FDA's expectations would be for 
clinical trials of new AEDs or the need for clinical trials for AED 
accessories given available less burdensome methods for obtaining 
performance data on accessories. Another comment requested 
clarification on whether AED manufacturers would be expected to re-test 
and re-validate older AED models to currently recognized standards. One 
comment requested clarification on when marketing materials for AEDs 
would need to comply with 21 CFR 801.109.
    One comment suggested that the 15-month period should be extended 
to 30 months, which the commenter claimed would be consistent with 
section 501(f)(2)(B) of the FD&C Act. One commenter requested 
clarification regarding whether the 15 months started at the 90th day 
after a final order was issued and another comment indicated that 15 
months should be sufficient, but that the 15 months should not include 
FDA's 180-day PMA review time. One comment suggested that FDA require 
PMAs 90 days after the final order.
    (Response 8) The data required to support premarket approval will 
vary by device and the specific data requirements. FDA is aware of 
clinical study information that can be leveraged for AEDs from both 
published studies and clinical data previously submitted to FDA under 
the 510(k) process, and, as was stated in the proposed order, FDA 
believes that many AED accessories ``may need to submit non-clinical 
performance testing with confirmatory animal studies in order to 
support independent PMA approval'' (78 FR 17890 at 17894, March 25, 
2013). Performance testing of AEDs must be provided in a PMA to support 
a reasonable assurance of safety and effectiveness. Although retesting 
older AED models to currently recognized standards is one way to meet 
the performance testing requirements, compliance with such standards is 
voluntary and manufacturers may submit a justification for how other 
testing conducted on their devices provides equivalent assurances of 
safety and effectiveness. FDA encourages manufacturers to proactively 
engage FDA via the pre-submission process to discuss the specific data 
needed for their PMAs (Ref. 4). FDA notes that existing prescription 
AEDs are already subject to 21 CFR 801.109, and will remain so after 
this call for PMAs. FDA review of AED PMAs will include review of the 
associated AED labeling to ensure such device labeling complies with 
regulatory requirements.
    FDA notes that the 30 months discussed in section 501(f)(2)(B) of 
the FD&C Act references the date from initial classification of a 
device into class III. AEDs have been classified as class III for more 
than 30 months, and hence this statutory provision has expired. FDA 
also acknowledges that it is in the interest of public health to ensure 
the availability of AEDs because they are life-saving devices and their

[[Page 5679]]

clinical use is well-established. After consideration of the comments, 
FDA continues to believe that the proposed 15 months for filing a PMA 
(Ref. 5) strikes an appropriate balance between the need to ensure 
continued availability of AEDs for the public health reasons stated 
previously and the implementation of PMA requirements to ensure the 
safety and effectiveness of AEDs.
    For currently marketed AEDs, FDA does not intend to enforce 
compliance with the 90-day deadline by which PMAs must be submitted for 
15 months after that deadline (i.e., 18 months after the effective date 
of the final order), as long as a notice of intent to file a PMA is 
submitted within 90 days of the effective date of the final order (see 
section V, ``Implementation Strategy''). Even if a notice of intent and 
PMA are submitted by these dates, manufacturers must cease distribution 
of devices upon receiving a not approvable or denial decision rendered 
on a PMA. To resume distribution, these manufacturers must receive PMA 
approval for their devices.
    Moreover, for currently marketed necessary AED accessories, FDA 
does not intend to enforce compliance with the 90-day deadline by which 
PMAs must be submitted for 57 months after that deadline (i.e., 5 years 
after the effective date of the final order) (see section V, 
``Implementation Strategy''). Continued availability of necessary AED 
accessories, including consumable accessory items (e.g., pad 
electrodes) and accessories with limited useful life (e.g., batteries), 
is critical to ensuring the safety and efficacy of currently marketed 
AEDs during the time while PMAs for those AEDs are being pursued. In 
addition, the continued availability of necessary accessories for 
``legacy devices''--individual AEDs that have been distributed and are 
currently in use (e.g., in public facilities, etc.) and for which the 
manufacturer is not seeking PMA approval for that AED model--ensures 
the availability of functional legacy AEDs until they are replaced with 
PMA-approved AEDs.
    (Comment 9) One commenter stated that FDA did not have a legal 
basis for continuing with finalization of a call for PMAs for AED 
systems because FDA failed to convene a panel as is required under 
FDASIA prior to issuing a final order. The commenter stated that FDA 
may not rely on the 2011 pre-FDASIA Panel because that Panel meeting 
was related to reclassifications under section 515(i) of the FD&C Act 
and not related to calls for PMAs under section 515(b). The commenter 
further contended that the 2011 Panel neither considered new 
information contained in a reclassification petition submitted to FDA 
in 2009 nor adequately discussed the appropriateness of class II 
special controls.
    (Response 9) FDA disagrees with the comment that FDA does not have 
a legal basis to finalize an order calling for PMAs for AED systems. 
Pursuant to FDASIA, the amendments to section 515(b) of the FD&C Act 
require, in relevant part, that issuance of an administrative order 
calling for PMAs for a preamendments device be preceded by a proposed 
order and a meeting of a classification panel. As amended, this section 
of the FD&C Act does not prescribe when these two events (the panel and 
proposed order) must occur in relation to each other. More importantly, 
FDA believes that the Panel's deliberations and recommendations remain 
relevant and fully satisfy the requirements in section 515(b) of FD&C 
Act.
    FDA disagrees with the comment that the Panel did not consider new 
information contained in the 2009 reclassification petition. A 
representative from the petitioner was present at the meeting and 
provided comments on the reclassification petition during the Panel 
meeting (Ref. 1). In addition, the petitioner was given an opportunity 
to explain the petitioner's reasons for why AEDs should be class II 
devices, including a discussion of the special controls described in 
the reclassification petition. Therefore, the Panel heard the 
petitioner's arguments and these arguments were available for the 
Panel's consideration when it made its recommendation.
    (Comment 10) One commenter objected to FDA's use of the term 
``diagnose'' in the proposed order to describe the functionality of 
AEDs (78 FR 17890 at 17893, March 25, 2013), and stated that AEDs sense 
shockable rhythms and are not diagnostic devices.
    (Response 10) FDA disagrees that these devices do not perform 
diagnostic functions. AEDs analyze and interpret ECG data to produce an 
assessment as to whether a shock should be delivered; while FDA does 
believe that AEDs have diagnostic functions, we note that the 
regulatory identification for the device in Sec.  870.5310(a), as 
finalized in the order, does not use the term diagnose, and instead 
describes the function of the device as ``analyzes'' and 
``interprets.''
    (Comment 11) One commenter stated that FDA's proposal to allow 
manufacturers to ``bundle'' several AED models under a single PMA is 
inconsistent with the PMA regulatory paradigm, which relies on a 
device-by-device assessment. The comment points to FDA's guidance on 
bundling, which states that ``[g]enerally, [manufacturers] should not 
bundle differing generic device types in a single PMA submission 
because of the substantially different pre-clinical and clinical data 
needed to support each of the devices'' (Ref. 6).
    (Response 11) FDA disagrees with the comment. Different AED models 
can be included in one PMA if they are the same generic device type. 
Because shock advisory algorithms and defibrillation waveforms will 
likely be common across various models from a given manufacturer of 
devices, FDA expects the clinical data needed to support devices within 
an appropriately bundled AED PMA to be the same. However, because of 
the differences in device labeling and user requirements between 
professional and lay use devices, FDA continues to believe that 
separate PMAs should be submitted for a manufacturer's professional use 
versus lay use devices. FDA believes this approach is least burdensome 
to manufacturers and is consistent with the bundling guidance, which 
states that ``[b]undling is appropriate for devices that present 
scientific and regulatory issues that can most efficiently be addressed 
during one review'' (Ref. 6).
    (Comment 12) One comment requested clarification on whether 
separate PMAs are required for AEDs and the associated AED accessories 
when a company manufacturers both for use together. Two comments 
requested additional clarification on whether accessories not specified 
in the proposed order (such as electrocardiograph modules and 
electrodes, training pads/batteries, protective carrying cases, 
Bluetooth modules, hardware keys or specialized pads to reduce energy 
for pediatric use, self-testers, SpO2/blood pressure 
monitoring devices, cardiopulmonary resuscitation (CPR) aids, medical 
device data systems (MDDS), etc.) would require PMAs. One comment 
suggested that AED accessories that are already 510(k) cleared should 
not be subject to premarket approval by virtue of being used with an 
AED.
    (Response 12) In response to this comment, FDA has revised the 
identification language to clarify that AED accessories regulated under 
Sec.  870.5310 are those accessories necessary for the AED to detect 
and interpret an electrocardiogram and deliver an electrical shock 
(e.g., battery, pad electrode, adapter, and hardware keys for pediatric 
use). Manufacturers of accessory devices that are not addressed by the 
final order and are not already

[[Page 5680]]

the subject of an existing classification regulation should contact 
FDA.
    Under the final order, manufacturers must submit PMAs for 
accessories that are necessary for operation of the AED system (e.g., 
accessories necessary to allow the AED to detect or interpret an 
electrocardiogram or deliver a defibrillation shock). These AED 
accessories include batteries, pad electrodes (including reduced energy 
pads for pediatric use), adapters, and hardware keys for pediatric use. 
In response to this comment, FDA has added ``hardware keys for 
pediatric use'' to the identification. Necessary AED accessories that 
are for use with a specific AED should be included in that PMA for the 
AED system as a whole. Alternatively, necessary AED accessories, 
including those manufactured by a third party, may be submitted in 
their own PMAs.
    Accessories that are not necessary for the functionality of the AED 
are not addressed by the final order. Currently marketed AED 
accessories that are not addressed by the final order, such as 
SpO2/blood pressure monitoring devices, ECG modules and 
testers, CPR aids, and MDDS, may be subject to other regulations and 
will continue to be subject to those existing regulations. Training 
accessories such as training pads and batteries for training-only AEDs 
are not currently subject to any additional regulations, and will not 
become so as a result of the final order.
    (Comment 13) One comment requested clarification regarding AEDs 
being considered adulterated 90 days after the effective date of a 
final order in the absence of submission of a statement of intent to 
submit a PMA or the submission of a full PMA. The comment questioned 
whether devices legally distributed prior to the 90th day could remain 
in distribution. Another comment requested clarification on whether 
manufacturers could continue to provide consumable accessory items 
(such as batteries and pads) for previously distributed devices even if 
a PMA will not be submitted for that AED model. Two comments requested 
clarification on how and whether manufacturers would be allowed to 
distribute components required for field servicing of a device, 
including refurbished replacement devices, before PMAs are submitted 
for the devices.
    (Response 13) Under the final order (see section IV, ``the Final 
Order'') and section 501(f)(2)(B) of the FD&C Act, PMAs must be 
submitted within 90 days after the effective date of the final order 
for currently marketed AED systems. If a PMA is not submitted, the 
devices are adulterated. However, for the reasons discussed previously, 
for currently marketed AEDs, FDA does not intend to enforce compliance 
with the 90-day deadline by which PMAs must be submitted for 15 months 
after that deadline (i.e., 18 months after the effective date of the 
final order), as long as a notice of intent to file a PMA is submitted 
within 90 days of the effective date of the final order (see section V, 
``Implementation Strategy''). For currently marketed necessary AED 
accessories, FDA also does not intend to enforce compliance with the 
90-day deadline by which PMAs must be submitted for 57 months after 
that deadline (i.e., 5 years after the effective date of the final 
order) (see section V, ``Implementation Strategy). This intention 
applies to necessary AED accessories regardless of whether a PMA is 
being or has been sought for the AED model.
    (Comment 14) One comment indicated that premarket review of medical 
devices such as AEDs should include review of the software embedded 
into the devices, including review of software verification and 
validation documentation. The comment noted that such review should 
also occur for software modifications and software developed for 
maintenance of the devices, including self-test functions. The comment 
relayed the importance of having reviewers with adequate training, 
expertise, and experience.
    (Response 14) FDA agrees with the comment. Review of AEDs under the 
510(k) process has included a detailed review of software documentation 
supporting premarket submissions by appropriately trained and 
experienced FDA reviewers. The PMA review will also involve a review of 
software documentation and will be conducted by trained and experienced 
FDA reviewers.
    (Comment 15) One comment suggested an alternative regulatory 
approach whereby AEDs for medical professional use be reclassified into 
class II and public access defibrillators used by laypersons remain in 
class III with PMAs required. The comment stated that professional use 
devices have advanced functionality and are operated by skilled and 
trained professionals, which lessens the chance of human factor errors 
and increases the likelihood that the user will be able to recognize 
and troubleshoot any malfunctions. The comment stated that such users 
can rely on past experience and other means of attempting to rescue a 
patient, whereas lay users are often fully reliant on the AED. Two 
comments also indicated that professional use devices are typically 
manual defibrillators with additional functionality, including AED, and 
that the proposed order would create an inconsistent system whereby the 
same hardware if used only for manual defibrillation would be class II, 
but by virtue of configuring the device to include AED functionality 
would become a PMA class III product.
    (Response 15) FDA disagrees with the comments and believes that the 
submission of PMAs is warranted regardless of the intended user of the 
device. FDA does not believe that there is sufficient information to 
establish special controls to provide a reasonable assurance of safety 
and effectiveness of the device regardless of the training of AED 
users.
    FDA recognizes that some manual defibrillators and AEDs share 
common hardware and software platforms, and hence devices with similar 
or identical platforms may receive different regulatory review based on 
the configuration. For the reasons previously stated, however, FDA 
continues to believe AED systems should be class III devices. FDA also 
notes that the performance and other data needed to support safety and 
effectiveness for hardware and software platforms for both types of 
devices would be nearly identical; the difference would be related to 
the amount of information that must be submitted to FDA. For a PMA, 
more information on the design controls process is required to be 
submitted whereas for a 510(k) submission, some information may not 
need to be submitted and instead can reside within the company's 
overall quality system and associated design documentation. Such 
situations of different regulatory processes have occurred in other 
product areas including contact lenses (daily-wear are typically class 
II, whereas extended wear are class III) and ablation devices (general 
surgical use are class II, whereas use for treatment of atrial 
fibrillation is class III), and FDA does not believe this changes the 
overall rationale supporting the need for PMAs.
    (Comment 16) Two comments noted that there are numerous companies 
that refurbish and/or resell AEDs. The comments requested that FDA 
include AED resellers and refurbishers in their consideration of 
regulatory strategy.
    (Response 16) Regardless of the supplier, the introduction or 
delivery for introduction into interstate commerce of any device that 
is adulterated is a prohibited act under section 301 of the FD&C Act 
(21 U.S.C. 331) (see Comment 12). FDA encourages refurbishers and 
resellers who have

[[Page 5681]]

questions about the continued distribution of AEDs to contact FDA via 
the pre-submission process.
    (Comment 17) One comment requested clarification of the process for 
modifications of currently marketed AEDs (and notifying FDA of such 
modifications) during the 90-day period after the final order is 
issued. One comment stated that given the nature of commercial, 
electrical and mechanical components used in AEDs, an extended 
transition period without the ability to implement changes would not be 
tenable and would result in unavailability of devices. One comment 
requested clarification on 510(k) submissions accepted for review, but 
for which no decision had been rendered, prior to the effective date of 
a final order calling for PMAs.
    (Response 17) Under Sec.  870.5310, as amended, all new AED and 
necessary AED accessories must have an approved PMA in effect before 
being placed in commercial distribution. We recommend that 
manufacturers of currently marketed AEDs contact FDA regarding 
implementation of any changes necessary for their AEDs in order to 
address safety concerns or to support ongoing distribution while PMA 
approval is being sought. FDA understands that issues may arise 
relating to part obsolescence or changes necessary to reduce a risk to 
health posed by a currently marketed AED that is not functioning 
properly.
    All other changes need to be accounted for in a PMA. Moreover, all 
new AED and necessary AED accessories must have an approved PMA in 
effect before being placed in commercial distribution.
    (Comment 18) One comment objected to the comparisons made by FDA at 
the 2011 Panel meeting between implanted cardioverter defibrillators 
(ICDs) (PMA devices) and AEDs. The comment noted the number of 
commercial components (e.g., components supplied to multiple industries 
for a variety of uses) in order to maintain affordable price-points for 
AEDs and the potentially burdensome PMA supplements that would be 
necessary to support incremental changes in manufacturing for AEDs. The 
comment further contended that purchased component-related recalls for 
AEDs have largely been a result of latent component failures and that 
FDA's examples at the 2011 Panel meeting of QS concerns related to 
changes to purchased components or device design would not have been 
averted by the stricter premarket regulatory oversight via PMA 
supplements.
    (Response 18) FDA acknowledges that more stringent regulatory 
oversight via the PMA process may not completely eliminate AED recalls. 
FDA also recognizes that AEDs typically contain commercial components 
and manufacturers will need to submit PMA supplements for changes to 
these components, as well as changes to suppliers and manufacturing 
processes. Use of commercial components in PMA devices is not uncommon 
and changes at the component level may have led to some AED recalls and 
adverse events, providing further support for increased regulatory 
review. FDA continues to believe that these failures and the need for 
careful consideration and adequate verification and validation of such 
changes support more rigorous review under the PMA process.
    (Comment 19) One comment requested clarification on activities 
during the time after a notice of intent to file is submitted, 
including whether FDA will place additional postmarket approval 
requirements on previously distributed products as allowed under 21 CFR 
814.82. The comment further asked whether IDEs would be required for 
design changes (e.g., would an IDE be required to conduct human 
factors/usability studies).
    (Response 19) FDA will consider the need for postapproval 
requirements in the context of each manufacturer's PMA submission and 
the devices in distribution. FDA does not intend to exempt 
manufacturers from the IDE requirements and hence any study which meets 
the IDE requirements must be conducted in accordance with the 
requirements of 21 CFR parts 50 and 812. There will be no extended 
period for filing an IDE and studies may not be initiated without 
appropriate IDE approvals. Manufacturers who have questions regarding 
whether an IDE is needed for a particular AED study are encouraged to 
interact with FDA via the pre-submission process.

IV. The Final Order

    FDA is adopting its findings as published in the preamble of the 
proposed order (78 FR 17890, March 25, 2013), with the addition of 
adverse tissue reaction as being identified as a risk to health in this 
final order, and is issuing this final order to require the filing of a 
PMA for AED systems under 515(b) of the FD&C Act. An AED system 
consists of an AED and those accessories necessary for the AED to 
detect and interpret an electrocardiogram and deliver an electrical 
shock (e.g., battery, pad electrode, adapter, and hardware keys for 
pediatric use). An AED system analyzes the patient's electrocardiogram, 
interprets the cardiac rhythm, and automatically delivers an electrical 
shock (fully automated AED), or advises the user to deliver the shock 
(semi-automated or shock advisory AED) to treat ventricular 
fibrillation or pulseless ventricular tachycardia. Under section 
515(b)(1)(A) of the FD&C Act, PMAs for AED systems are required to be 
filed on or before 90 days after the effective date of a final order. 
This final order will revise 21 CFR part 870.

V. Implementation Strategy

    Based on comments on the proposed order, we are clarifying FDA's 
intentions regarding enforcing compliance with the final order (see 
section IV, ``The Final Order'') and section 501(f)(2)(B) of the FD&C 
Act.

A. Currently Marketed AEDs

    Under the final order and section 501(f)(2)(B) of the FD&C Act, 
PMAs for currently marketed AEDs are required to be filed on or before 
90 days after the effective date of a final order. However, for 
currently marketed AEDs, FDA does not intend to enforce compliance with 
this 90-day deadline for 15 months after that deadline (i.e., 18 months 
after the effective date of the final order), as long as notice of 
intent to file a PMA is submitted within 90 days of the effective date 
of the final order. The notification of the intent to file a PMA 
submission must include a list of all model numbers for which a 
manufacturer plans to seek marketing approval through a PMA.
    In conducting any clinical studies, AEDs may be distributed for 
investigational use if the requirements of the IDE regulations (21 CFR 
part 812) are met. There will be no extended period for filing an IDE 
nor exemption from IDE requirements, and studies may not be initiated 
without appropriate IDE approvals, where necessary.

B. Currently Marketed Necessary AED Accessories

    Under the final order and section 501(f)(2)(B), PMAs for currently 
marketed necessary AED accessories are required to be filed on or 
before 90 days after the effective date of this final order. However, 
for currently marketed necessary AED accessories, FDA does not intend 
to enforce compliance with this 90-day deadline for 57 months after the 
deadline (i.e., 5 years after the effective date of the final order). 
Currently marketed necessary AED accessory manufacturers are not 
required to file an intent-to-file by the 90-day deadline.
    After the effective date of the final order, new AEDs and necessary 
AED accessories must have approved PMAs

[[Page 5682]]

to be legally marketed. The following tables show the regulatory 
timetable for currently marketed AEDs and necessary AED accessories.

                    Table 1--Currently Marketed AEDs
------------------------------------------------------------------------
                                  Timetable for
                                  which FDA does
                                  not intend to     Distribution period
                                     enforce       (time after effective
                                compliance  (time      date of order)
                                 after effective
                                  date of order)
------------------------------------------------------------------------
Intent to File a PMA..........  90 days..........  Devices included in
                                                    an intent to file:
                                                    18 months.
                                                   Devices not included
                                                    in intent to file:
                                                    90 days.
File a PMA....................  18 months........  Until a not
                                                    approvable decision
                                                    or denial decision
                                                    is issued; can
                                                    continue
                                                    distribution if an
                                                    approval order is
                                                    issued.
------------------------------------------------------------------------


          Table 2--Currently Marketed Necessary AED Accessories
------------------------------------------------------------------------
                                  Timetable for
                                  which FDA does
                                  not intend to     Distribution period
                                     enforce       (time after effective
                                 compliance (time      date of order)
                                 after effective
                                  date of order)
------------------------------------------------------------------------
Intent to File a PMA..........  N/A..............  N/A.
File a PMA....................  60 months........  Until a not
                                                    approvable decision
                                                    or denial decision
                                                    is issued; can
                                                    continue
                                                    distribution if an
                                                    approval order is
                                                    issued.
------------------------------------------------------------------------

VI. Environmental Impact

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

VII. Paperwork Reduction Act of 1995

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

VIII. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) of the FD&C Act 
provided for FDA to issue regulations to require PMA approval for 
preamendments devices or devices found substantially equivalent to 
preamendments devices. Section 515(b) of the FD&C Act, as amended by 
FDASIA, provides for FDA to require PMA approval for such devices by 
issuing a final order, following the issuance of a proposed order in 
the Federal Register. FDA will continue to codify the requirement for a 
PMA approval in the Code of Federal Regulations. Therefore, under 
section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in this 
final order, we are requiring PMA approval for AED systems and we are 
making the language in Sec.  870.5310 consistent with the final version 
of this order.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. Meeting Materials for 515(i) Regulatory Classification of 
Automated External Defibrillator Systems, January 25, 2011, 
available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm240575.htm.
2. FDA will respond separately to the reclassification petition and 
will address the issues raised in that petition in its response; 
certain issues, however, may be addressed in both this document and 
the petition response due to the overlapping discussions in those 
documents. The reclassification petition is available at http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-0234-0002.
3. U.S. Food and Drug Administration, Medical Device Recalls 
Database, available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm.
4. Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with Food and Drug Administration 
Staff, Guidance for Industry and Food and Drug Administration Staff, 
February 18, 2014, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.
5. Acceptance and Filing Reviews for Premarket Approval Applications 
(PMAs), Guidance for Industry and Food and Drug Administration 
Staff, December 31, 2012, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313368.pdf.
6. Guidance for Industry and FDA Staff: Bundling Multiple Devices or 
Multiple Indications in a Single Submission, June 22, 2007, 
available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089731.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 870.5310 is amended by revising the section heading and 
paragraphs (a) and (c) to read as follows:

[[Page 5683]]

Sec.  870.5310  Automated external defibrillator system.

    (a) Identification. An automated external defibrillator (AED) 
system consists of an AED and those accessories necessary for the AED 
to detect and interpret an electrocardiogram and deliver an electrical 
shock (e.g., battery, pad electrode, adapter, and hardware key for 
pediatric use). An AED system analyzes the patient's electrocardiogram, 
interprets the cardiac rhythm, and automatically delivers an electrical 
shock (fully automated AED), or advises the user to deliver the shock 
(semi-automated or shock advisory AED) to treat ventricular 
fibrillation or pulseless ventricular tachycardia.
* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA will 
be required to be submitted to the Food and Drug Administration by May 
4, 2015, for any AED that was in commercial distribution before May 28, 
1976, or that has, by May 4, 2015, been found to be substantially 
equivalent to any AED that was in commercial distribution before May 
28, 1976. A PMA will be required to be submitted to the Food and Drug 
Administration by May 4, 2015, for any AED accessory described in 
paragraph (a) of this section that was in commercial distribution 
before May 28, 1976, or that has, by May 4, 2015, been found to be 
substantially equivalent to any AED accessory described in paragraph 
(a) that was in commercial distribution before May 28, 1976. Any other 
AED and AED accessory described in paragraph (a), shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

    Dated: January 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02049 Filed 2-2-15; 8:45 am]
BILLING CODE 4164-01-P