Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations 4783 

Dated: January 23, 2015. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2015–01639 Filed 1–28–15; 8:45 am] 

BILLING CODE 3510–33–P 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

issuing a final order to require 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 January 

29, 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, linda.ricci@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (Pub. L. 101–629), the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115), the Medical 

Device User Fee and Modernization Act 

of 2002 (Pub. L. 107–250), the Medical 

Devices Technical Corrections Act (Pub. 

L. 108–214), the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85), and the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA) (Pub. L. 112– 

144), among other amendments, 

established a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the FD&C Act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, reflecting the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

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 

(21 U.S.C. 360c(d)), 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 (21 U.S.C. 

360c(f)) 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 (21 U.S.C. 360c(i)), 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 (21 U.S.C. 360e(b)(1)) 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 (21 U.S.C. 360e(b)), 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 (21 U.S.C. 360c(e)), 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 

(21 U.S.C. 360e(b)) 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 (21 

U.S.C. 351(f)(2)(B)) requires that a PMA 


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4784 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations 

1FDA will respond separately to the 

reclassification petition and will address the issues 

raised in that petition in its response. The 

reclassification petition is available at http://

www.regulations.gov/#!documentDetail;D=FDA2013-N-0234-0002. 

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 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 (21 U.S.C. 360e) 

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 (21 U.S.C. 

351(f)(1)(A)), 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 

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).1 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 (21 U.S.C. 360c(a)(1)(C))). 

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 


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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Rules and Regulations 4785 

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 premarket 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 (21 U.S.C. 

360c(a)(1)(C))). 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. Further, under section 

513(f)(5) of the FD&C Act (21 U.S.C. 

360c(f)(5)), 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 (21 

U.S.C. 360e(c)(1)(C)), 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 21 

CFR 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 above, 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 

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 above). 

(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 above, FDA does not believe that 


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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 

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 selftest 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. 2). 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) 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 retest 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 (21 U.S.C. 

351(f)(2)(B). 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 7) 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 nonclinical performance testing with 

confirmatory animal studies in order to 

support independent PMA approval’’ 

(78 FR 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 


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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. 3). 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 (21 U.S.C. 351(f)(2)(B)) 

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 clinical use 

is well-established. After consideration 

of the comments, FDA continues to 

believe that the proposed 15 months for 

filing a PMA (Ref. 4) strikes an 

appropriate balance between the need to 

ensure continued availability of AEDs 

for the public health reasons stated 

above 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 8) 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 (21 U.S.C. 

360e(i)) and not related to calls for 

PMAs under section 515(b) of the FD&C 

Act (21 U.S.C. 360e(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 8) 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 9) One commenter objected 

to FDA’s use of the term ‘‘diagnose’’ in 

the proposed order to describe the 

functionality of AEDs (78 FR 17893, 

March 25, 2013), and stated that AEDs 

sense shockable rhythms and are not 

diagnostic devices. 

(Response 9) 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 21 CFR 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 10) 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-bydevice 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. 5). 

(Response 10) 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. 5). 

(Comment 11) One comment 

requested clarification on whether 


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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 11) In response to this 

comment, FDA has revised the 

identification language to clarify that 

AED accessories regulated under 21 CFR 

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 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 12) 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 12) 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 above, 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 13) 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 13) 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 14) 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 14) 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 


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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 15) 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 15) 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 

questions about the continued 

distribution of AEDs to contact FDA via 

the pre-submission process. 

(Comment 16) 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 16) Under 21 CFR 

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 17) 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 17) 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 18) 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 18) 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) and issuing this final order to 

require the filing of a PMA for AED 

systems under 515(b) of the FD&C Act 

(21 U.S.C. 360e(b)). 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 (21 

U.S.C. 360e(b)(1)(A)), 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 (21 

U.S.C. 351(f)(2)(B)). 

A. Currently Marketed AEDs 

Under the final order and section 

501(f)(2)(B) (21 U.S.C. 351(f)(2)(B)), 

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 


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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) (21 U.S.C. 351(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 

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 

enforce compliance 

(time after effective date of order) 

Distribution period 

(time 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 

enforce compliance 

(time after effective date of order) 

Distribution period 

(time 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 (21 

U.S.C. 360e(b)) 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 (21 U.S.C. 

360e(b)), 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 (21 U.S.C. 360e(b)(1)(A)), as 

amended by FDASIA, in this final order, 

we are requiring PMA approval for AED 

systems and we are making the language 

in 21 CFR 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 address, but FDA is not 

responsible for any subsequent changes 

to the Web site 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. U.S. Food and Drug Administration, 

Medical Device Recalls Database, available at 

http://www.accessdata.fda.gov/scripts/cdrh/

cfdocs/cfRES/res.cfm. 

3. 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. 

4. 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. 

5. 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. 


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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 

■ 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. 

■ 2. Section 870.5310 is amended by 

revising the section heading and 

paragraphs (a) and (c) to read as follows: 

§ 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 (semiautomated 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 April 29, 

2015, for any AED that was in 

commercial distribution before May 28, 

1976, or that has, by April 29, 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 April 29, 2015, for 

any AED accessory described in 

paragraph (a) that was in commercial 

distribution before May 28, 1976, or that 

has, by April 29, 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 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01619 Filed 1–28–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9709] 

RIN 1545–BK64 

Application for Recognition as a 

501(c)(29) Organization 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations and removal of 

temporary regulations. 

SUMMARY: This document contains final 

regulations authorizing the IRS to 

prescribe the procedures by which 

certain entities may apply to the IRS for 

recognition of exemption from Federal 

income tax. These regulations affect 

qualified nonprofit health insurance 

issuers participating in the Consumer 

Operated and Oriented Plan program 

established by the Centers for Medicare 

and Medicaid Services that seek 

exemption from federal income tax 

under the Internal Revenue Code. 

DATES: Effective date: These regulations 

are effective on January 29, 2015. 

Applicability date: For date of 

applicability, see § 1.501(c)(29)–1(c). 

FOR FURTHER INFORMATION CONTACT: 

Martin Scha ̈ffer, (202) 317–5800 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

Section 501(c)(29) of the Internal 

Revenue Code (Code) provides 

requirements for tax exemption under 

section 501(a) for qualified nonprofit 

health insurance issuers (QNHIIs). 

Section 501(c)(29) was added to the 

Code by section 1322(h)(1) of the Patient 

Protection and Affordable Care Act, 

Public Law 111–148 (March 23, 2010) 

(Affordable Care Act). 

Section 1322 of the Affordable Care 

Act directs the Centers for Medicare and 

Medicaid Services (CMS) to establish 

the Consumer Operated and Oriented 

Plan (CO–OP) program. The purpose of 

the CO–OP program is to foster the 

creation of member-governed QNHIIs 

that will operate with a strong consumer 

focus and offer qualified health plans in 

the individual and small group markets. 

CMS provides loans and repayable 

grants (collectively, loans) to 

organizations applying to become 

QNHIIs to help cover start-up costs and 

meet any solvency requirements in 

States in which the organization is 

licensed to issue qualified health plans. 

For each loan, CMS issues a Notice of 

Award and Loan Agreement to the 

QNHII. The appropriate officer of the 

QNHII or of the QNHII’s board of 

directors must sign and return the loan 

agreement to CMS. On December 13, 

2011, CMS issued final regulations 

implementing the CO–OP program at 76 

FR 77392. 

The CMS final regulations define a 

QNHII as an entity that, within specified 

time frames, satisfies or can reasonably 

be expected to satisfy the standards in 

section 1322(c) of the Affordable Care 

Act and in the CMS final regulations. 

The entity will constitute a QNHII until 

such time as CMS determines the entity 

does not satisfy or cannot reasonably be 

expected to satisfy these standards. 

Section 1322(c) of the Affordable Care 

Act imposes a number of requirements, 

including that a QNHII be organized as 

a nonprofit member corporation under 

State law and that substantially all its 

activities consist of the issuance of 

qualified health plans in the individual 

and small group markets in each State 

in which it is licensed to issue such 

plans. 

Section 501(c)(29)(A) of the Code 

provides that a QNHII (within the 

meaning of section 1322(c) of the 

Affordable Care Act) which has received 

a loan or grant under the CO–OP 

program may be recognized as exempt 

from taxation under section 501(a), but 

only for periods for which the 

organization is in compliance with the 

requirements of section 1322 of the 

Affordable Care Act and any loan or 

grant agreement with the Secretary of 

Health and Human Services. Section 

501(c)(29)(B) provides that a QNHII will 

not qualify for tax-exemption unless it 

meets four additional requirements. 

First, the QNHII must give notice to the 

Secretary of the Treasury, in such 

manner as the Secretary may by 

regulations prescribe, that it is applying 

for recognition of exemption as an 

organization described in section 

501(c)(29). Second, no part of the 

QNHII’s net earnings may inure to the 

benefit of any private shareholder or 

individual, except to the extent 

permitted by section 1322(c)(4) of the 

Affordable Care Act (which requires that 

any profits be used to lower premiums, 

to improve benefits, or for other 

programs intended to improve the 

quality of health care delivered to the 

organization’s members). Third, no 

substantial part of the QNHII’s activities 


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