Document ID: FDA-2013-N-0234-0001
Agency: fda
Document Type: Proposed Rule
Title: Effective Dates of Requirements for Premarket Approvals: Automated External Defibrillator System
Posted Date: 2013-03-25T04:00Z

[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Proposed Rules]
[Pages 17890-17895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06723]

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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 System.

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require 
the filing of a premarket approval application (PMA) or a notice of 
completion of a product development protocol (PDP) for the following 
class III preamendments devices: Automated external defibrillators 
systems (AEDs), which includes the AED device and its accessories 
(i.e., pad electrodes, batteries, and adapters). The Agency is also 
summarizing its proposed findings regarding the degree of risk of 
illness or injury designed to be eliminated or reduced by requiring 
this device to meet the statute's premarket approval requirements and 
the benefits to the public from the use of the device. In addition, FDA 
is announcing the opportunity for interested persons to request that 
the Agency change the classification of the automated external 
defibrillator based on new information. This action implements certain 
statutory requirements.

DATES: Submit either electronic or written comments by June 24, 2013. 
FDA intends that, if a final order based on this proposed order is 
issued, anyone who wishes to continue to market the device will need to 
submit a PMA within 90 days of the publication date of the final order. 
Please see section III for more information about submitting a PMA. 
Please also see section IX for the proposed effective date of any final 
order that may publish based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0234, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:

[[Page 17891]]

     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-0234 for this order. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1646, Silver Spring, MD 20993-0002, 301-796-5616, 
Melissa.Burns@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 of 2004 
(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) establish 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 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 may be marketed without submission of a PMA 
until FDA issues a final order under section 515(b) of the FD&C Act (21 
U.S.C. 360e(b)) requiring premarket approval. 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 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(b) of FDASIA (126 
Stat. 1056) amended section 515(b) of the FD&C Act, changing the 
process for requiring premarket approval for a preamendments class III 
device from rulemaking to an administrative order.
    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: publication of a proposed order in 
the Federal Register, a meeting of a device classification panel 
described in section 513(b) of the FD&C Act, and consideration of 
comments from all affected stakeholders, including patients, payors, 
and providers. FDA has held a meeting of a device classification panel 
described in section 513(b) of the FD&C Act with respect to AEDs, and 
therefore, has met this requirement under section 515(b)(1) of the FD&C 
Act. As explained further in section IV, a meeting of a device 
classification panel described in section 513(b) of the FD&C Act took 
place in 2011 (Ref. 1) to discuss whether AEDs should be reclassified 
or remain in class III. The panel recommended that because AEDs are 
lifesaving devices it is appropriate to regulate them in class III. 
Furthermore, the problems with medical device reporting (MDR) systems 
and recalls indicate that having these devices regulated under 510(k) 
has not been successful. FDA also considered information it received, 
pertaining to AEDs, in response to the Agency's order (74 FR 16214, 
April 9, 2009) requiring manufacturers to submit information about a 
number of preamendments devices under section 515(i) of the FD&C Act. 
Moreover, FDA is not aware of new information that would provide a 
basis for a different recommendation or findings. Information received 
since the 2011 panel meeting and discussed further in section IV.B only 
further highlights the need to review these devices under a PMA and 
reinforces the recommendation and findings of the panel.
    Section 515(b)(2) of the FD&C Act provides that a proposed order to 
require premarket approval shall contain: (1) The proposed order; (2) 
proposed findings with respect to the degree of risk of illness or 
injury designed to be eliminated or reduced by requiring the device to 
have an approved PMA or a declared completed PDP and the benefit to the 
public from the use of the device; (3) an opportunity for the 
submission of comments on the proposed order and the proposed findings; 
and (4) an opportunity to request a change in the classification of the 
device based on new information relevant to the classification of the 
device.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after 
the close of the comment period on the proposed

[[Page 17892]]

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. If FDA terminates the proceeding, FDA is required to 
initiate reclassification of the device under section 513(e) of the 
FD&C Act, unless the reason for termination is that the device is a 
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
    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 (section 501(f) 
of the FD&C Act). For AEDs, the preamendments class III devices that 
are the subject of this proposal, the later of these two time periods 
is the 90-day period. Since these devices were classified in 2003, the 
30-month period has expired (see 68 FR 61342, October 28, 2003). If a 
PMA is not filed for such devices within 90 days after the issuance of 
a final order, the devices would be deemed adulterated under section 
501(f) of the FD&C Act.
    However, because of the widespread distribution of AEDs, we are 
proposing to consider exercising enforcement discretion for devices 
lawfully distributed before the requirement to have a PMA goes into 
effect as long as manufacturers of such devices timely notify FDA of 
their intent to file a PMA within 90 days from the issuance of the 
final order. FDA intends to consider exercising enforcement discretion 
for 15 months from the date the final order is issued.
    In accordance with section 515(b) of the FD&C Act, interested 
persons are being offered the opportunity to request reclassification 
of AEDs and AED accessories, the preamendments class III devices that 
are the subject of this proposed order.

II. Regulatory History of the Device

    Low energy DC-defibrillators are preamendment class II devices 
under 21 CFR 870.5300. Arrhythmia detectors and alarms are also 
preamendment devices that were once classified as class III devices 
under 21 CFR 870.1025. AEDs were found substantially equivalent to the 
preamendment class III arrhythmia detector and alarm devices in 
response to a 510(k) in 1985, because the submission was a combination 
of the class II low energy defibrillator and the class III arrhythmia 
detector and alarm. FDA found AEDs equivalent to the higher class of 
the combined devices, and thus, AEDs were classified as class III 
devices. On October 28, 2003 (68 FR 61342), FDA published a final rule 
reclassifying arrhythmia detector and alarm devices into class II 
(special controls). In that rule, FDA also established a separate 
classification regulation for AEDs under Sec.  870.5310 (21 CFR 
870.5310) that retained these devices in class III and stated that it 
would address, at a later date, the possible reclassification of AEDs.

III. Dates New Requirements Apply

    In accordance with section 515(b) of the FD&C Act, FDA is proposing 
to require that a PMA be filed with the Agency for AED devices and 
accessories within 90 days after issuance of any final order based on 
this proposal. An applicant whose device was legally in commercial 
distribution before May 28, 1976, or whose device has been found to be 
substantially equivalent to such a device, will be permitted to 
continue marketing such class III devices during FDA's review of the 
PMA provided that a PMA is timely filed. FDA intends to review any PMA 
for the device within 180 days. FDA cautions that under section 
515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an 
agreement to extend the review period for a PMA beyond 180 days unless 
the Agency finds that ``the continued availability of the device is 
necessary for the public health.''
    Under the FD&C Act, AEDs and AED accessories currently in 
distribution for which no PMA is submitted within 90 days of a final 
order calling for PMAs, or for which a denial is rendered on its filed 
PMA, will be considered adulterated under section 501(f)(1) of the FD&C 
Act. As discussed in the paragraphs that follow, FDA believes that most 
AED manufacturers already have the clinical data they need to support a 
PMA. Nonetheless, because FDA recognizes that continued access to AEDs 
is important to the public health, FDA is proposing to consider 
exercising enforcement discretion for manufacturers of currently 
marketed AEDs, AED devices or accessories who cannot timely submit a 
PMA, but instead notify FDA of their intent to file a PMA within 90 
days from the issuance of the final order based on this proposal. The 
notification of the intent to file a PMA submission should include a 
list of all model numbers for which a manufacturer plans to seek 
marketing approval through its PMA. FDA proposes further to consider 
exercising enforcement discretion for 15 months from the issuance of a 
final order requiring the filing of a PMA for such devices. 
Manufacturers should be able to collect additional scientific evidence, 
to the extent any is necessary, and prepare PMA submissions, in this 
time. No new devices will be allowed into interstate commerce without 
approval of a PMA. We request comment on whether it is appropriate to 
exercise enforcement discretion and, if so, whether the 15-month period 
proposed is reasonable.
    FDA intends that under Sec.  812.2(d) (21 CFR 812.2(d)), the 
publication in the Federal Register of any final order based on this 
proposal will include a statement that, as of the date on which the 
filing of a PMA is required, the exemptions from the requirements of 
the investigational device exemption (IDE) regulations for 
preamendments class III devices in Sec.  812.2(c)(1) and (c)(2) will 
cease to apply to any device that is: (1) Not legally on the market on 
or before that date, or (2) legally on the market on or before that 
date but for which a PMA is not filed by that date, or for which PMA 
approval has been denied or withdrawn.
    However, FDA intends to exercise enforcement discretion concerning 
IDE and PMA requirements for manufacturers of AEDs, AED devices and/or 
accessories who notify FDA of their intent to file a PMA for such 
devices within 90 days and file a PMA within 15 months after the date 
of issuance of any final order requiring premarket approval for these 
devices. FDA is aware that many existing AED manufacturers have already 
obtained significant clinical data on their devices. In most cases, FDA 
believes the clinical data that has been submitted for AEDs in 510(k) 
applications will suffice as valid scientific evidence necessary to 
support a PMA. However, a small number of manufacturers may need to 
conduct an additional investigation to support approval. In those 
circumstances, FDA will consider the least burdensome means of 
gathering information, and will consider whether reliance on post-
market controls can reduce the extent of data that would otherwise be 
required to show effectiveness. FDA recommends that manufacturers file 
a pre-submission to discuss data requirements that may be necessary to 
support their individual PMA submission.

[[Page 17893]]

IV. Benefits of AED Systems

A. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the FD&C Act, FDA is publishing 
its proposed findings regarding: (1) The degree of risk of illness or 
injury designed to be eliminated or reduced by requiring that this 
device have an approved PMA, and (2) the benefits to the public from 
the use of the device.
    These findings are based on the reports and recommendations of the 
advisory committee for the classification of this device along with 
information submitted in response to the 515(i) order (74 FR 16214) and 
any additional information that FDA has obtained. Additional 
information regarding the risks as well as classification associated 
with this device type can be found in the following proposed and final 
orders and notices published in the Federal Register on the following 
dates: October 28, 2003 (68 FR 61342) and March 8, 2004 (69 FR 10615).

B. Device Subject to This Proposal--Automated External Defibrillator 
(Sec.  870.5310)

1. Identification
    An AED system consists of an AED device and its accessories, i.e., 
battery, pad electrode and, if applicable, an adapter. 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.
2. Summary of Data
    In response to the 515(i) order (74 FR 16214), manufacturers 
provided information to FDA that they believe supports reclassification 
of AED devices from class III to class II. One manufacturer submitted a 
reclassification petition to the Docket (FDA-2009-M-0101). The primary 
basis presented by the manufacturer for reclassification was that 
special controls could provide reasonable assurance of the safety and 
effectiveness of AEDs. Examples of applicable special controls that 
were cited include testing to industry standards, guidelines, device 
labeling, guidance documents, and postmarket surveillance.
    A meeting of the Circulatory System Devices Panel (``Panel'') was 
held on January 25, 2011 (Ref. 1). The Panel discussed and made 
recommendations regarding the regulatory classification of AEDs to 
either reconfirm to class III (subject to premarket approval 
application) or reclassify to class II (subject to special controls), 
as directed by section 515(i) of the FD&C Act (21 U.S.C. 360e(i)).
    FDA's presentation to the Panel included a summary of the adverse 
event reports and recalls received by FDA on AED systems. This summary 
indicated that the total number of MDRs submitted annually more than 
doubled from 2005 to 2010. A review of reports submitted from 2011 and 
2012 shows that the number of submitted adverse events reports has 
continued to increase. Annual reporting (which occurs with PMA devices) 
would improve overall surveillance by providing denominator data for 
device distribution as well as current trend information on issues 
being followed by the manufacturer.
    FDA's analysis of recalls associated with AEDs systems indicated 
that the majority of recalls were associated with a manufacturer's 
handling of purchasing controls (21 CFR 820.50) or design controls (21 
CFR 820.30). In addition, FDA's analysis also noted the significant 
number of violative AED manufacturing facility inspections. FDA 
concluded from the recall and inspection information that the following 
requirements that are a part of the PMA process should be placed on AED 
manufacturers: (1) Premarket review of manufacturing information, 
including procedures and processes to ensure compliance with the 
requirements of 21 CFR part 820 (Quality System (QS) Regulation), (2) 
pre-approval inspections to determine manufacturers' compliance with 
the QS regulation to assure that the manufacturer's quality system is 
in place and appears to be adequate prior to manufacture and 
distribution of devices, (3) review of changes in manufacturing 
facilities to ensure facility, procedures, and systems are adequate, 
and (4) additional postmarket assurances available for PMA devices 
including the postmarket review of significant manufacturing changes to 
ensure that the changes are adequately evaluated.
    Accordingly, FDA stated that the devices should remain in class 
III, and require PMAs, because of the level of regulatory control 
necessary to provide reasonable assurance of safety and effectiveness, 
including: premarket review of manufacturing information; pre-approval 
inspections; review of changes in manufacturing facility location where 
finished devices are manufactured; postmarket review of significant 
manufacturing changes to ensure that the changes are adequately 
evaluated and tested prior to implementation; and annual reporting of 
device performance. The majority of the Panel members recommended the 
reconfirmation of AEDs as class III devices. The Panel expressed 
significant concerns that the number of adverse events reported in MDRs 
and the increase in recalls indicate that regulating these devices 
under premarket notification has not been successful. Therefore, 
increased regulatory oversight would be prudent. The panel transcript 
and other meeting materials are available on FDA's Web site (Ref. 1).
    The AED system is composed of the AED device and its accessories, 
i.e., pad electrodes, battery, and adapters. The reports of MDRs and 
recalls associated with AED devices have also included failures related 
to pad electrodes, batteries and adapters. Because failure of the pad 
electrode, battery or adapter results in the same risks to health as 
failure of the AED, these devices should be subject to the same 
regulatory oversight as the AEDs themselves to provide reasonable 
assurance of safety and effectiveness for the entire AED system. Thus, 
this proposed order confirms the classification of AED accessories as 
class III devices and requires that manufacturers of AED accessories 
submit PMAs for their devices.
 3. Risks to Health
    AEDs are devices that diagnose life-threatening abnormal heart 
rhythms, and treat them by delivering defibrillation shocks to the 
heart to restore its normal rhythm. Defibrillation shocks are used to 
treat patients with ventricular fibrillation (VF) or pulseless 
ventricular tachycardia (VT). AEDs should be able to be deployed 
quickly to provide defibrillation shocks to patients with VF or 
pulseless VT. These patients' survival depends upon a rapid sequence of 
rescue events that includes the successful delivery of a defibrillation 
shock from an AED. Rescuers have only minutes before these patients' 
heart rhythms degenerate beyond rescue capabilities.
    a. Failure or delay to deliver a defibrillation shock. One risk to 
health associated with AEDs is that these devices can malfunction and 
fail to deliver a defibrillation shock to a patient in VF or pulseless 
VT. Such failure can result in permanent injury or prevent the rescue 
of the patient.
    b. Inappropriate cardiac rhythm detection. AEDs should be able to 
recognize shockable and non-shockable algorithms. Shockable rhythms 
include VF and pulseless VT. Non-shockable

[[Page 17894]]

rhythms include normal sinus rhythm, supraventricular tachycardia, 
asystole, atrial fibrillation, sinus bradycardia, atrial flutter, and 
pulseless electrical activity. If the AED does not appropriately 
recognize a patient's cardiac rhythm it can fail to deliver or 
recommend a defibrillation shock to a shockable rhythm, or deliver or 
recommend a defibrillation shock to a non-shockable rhythm. Failure to 
deliver a defibrillation shock to a patient in VF or VT may result in 
death or permanent impairment of the patient. If the device delivers an 
inappropriate defibrillation shock to a patient in normal sinus rhythm 
it may induce ventricular fibrillation.
    c. Inadvertent shocks to rescuers or bystanders. There is the 
potential risk of delivering an electrical shock during defibrillation 
of a patient to a rescuer or bystander if there is physical contact 
between them and the patient, or if there is a malfunction in the pad 
electrodes or device. There is concern that an inadvertent shock to a 
rescuer or bystander could induce cardiac arrhythmias or ventricular 
fibrillation.
4. Benefits of AED Systems
    AEDs have a rhythm recognition detection system that delivers an 
electrical shock to treat VF or pulseless VT. The delivery of this 
therapy can be either fully automatic or semiautomatic. These devices 
are intended to be used on suspected victims of sudden cardiac arrest 
who are unresponsive and not breathing normally. AEDs are an important 
tool in providing a rapid response to victims of cardiac arrest and are 
successful at resuscitating victims of cardiac arrest by restoring 
normal cardiac rhythm.

V. PMA Requirements

    A PMA for this device must include the information required by 
section 515(c)(1) of the FD&C Act. Such a PMA should also include a 
detailed discussion of the risks identified previously, as well as a 
discussion of the effectiveness of the device for which premarket 
approval is sought. In addition, a PMA must include all data and 
information on: (1) Any risks known, or that should be reasonably 
known, to the applicant that have not been identified in this document; 
(2) the effectiveness of the device that is the subject of the 
application; and (3) full reports of all preclinical and clinical 
information from investigations on the safety and effectiveness of the 
device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (Sec.  860.7(c)(2) (21 CFR 860.7(c)(2))). Valid 
scientific evidence is ``evidence from well-controlled investigations, 
partially controlled studies, studies and objective trials without 
matched controls, well-documented case histories conducted by qualified 
experts, and reports of significant human experience with a marketed 
device, from which it can fairly and responsibly be concluded by 
qualified experts that there is reasonable assurance of the safety and 
effectiveness of a device under its conditions of use. * * * Isolated 
case reports, random experience, reports lacking sufficient details to 
permit scientific evaluation, and unsubstantiated opinions are not 
regarded as valid scientific evidence to show safety or 
effectiveness.'' (Sec.  860.7(c)(2)).
    For those manufacturers with multiple AED devices in their 
portfolio, a single PMA may be submitted for AEDs that are intended for 
lay users (public access AEDs) and another PMA for AEDs that 
incorporate additional functionality for medical professionals such as 
manual defibrillation, monitoring features, etc. (hospital use and 
emergency responder AEDs). Manufacturers of pad electrodes, batteries, 
and adapters may submit PMAs for the accessories they manufacture, 
which must be supported by valid scientific evidence that these 
accessory devices operate as intended when paired with a given AED(s) 
and are appropriately labeled to ensure use only with supported AEDs.
    AED manufacturers will need to submit performance testing, 
including clinical trials of their device, in order to support PMA 
approval. FDA anticipates that many existing AED manufacturers have 
already obtained significant clinical data that may be sufficient to 
support PMA approval. Existing published clinical literature may also 
be leveraged as part of the PMA submission. Manufacturers of batteries, 
adapters, and pad electrode manufacturers may need to submit non-
clinical performance testing with confirmatory animal studies in order 
to support independent PMA approval. Battery and adapter manufacturers 
may need to submit only bench testing. However, pad electrode 
manufacturers may need to submit animal studies in addition to bench 
testing if concerns arise during the premarket review process on 
defibrillation success or post-shock dysfunction. We request comment on 
the performance and clinical data requirements for AEDs and related 
devices.

VI. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA, FDA is required by section 
515(b)(2)(D) of the FD&C Act to provide an opportunity for interested 
persons to request a change in the classification of the device based 
on new information relevant to the classification. Any proceeding to 
reclassify the device will be under the authority of section 513(e) of 
the FD&C Act.
    A request for a change in the classification of this device is to 
be in the form of a reclassification petition containing the 
information required by 21 CFR 860.123, including new information 
relevant to the classification of the device.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This proposed order refers to collections of information that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
    The collections of information in 21 CFR part 814 have been 
approved under OMB control number 0910-0231. The collections of 
information in part 807, subpart E, have been approved under OMB 
control number 0910-0120. The effect of this order, if finalized, is to 
shift certain devices from the 510(k) premarket notification process to 
the PMA process. To account for this change, FDA intends to transfer 
some of the burden from OMB control number 0910-0120, which is the 
control number for the 510(k) premarket notification process, to OMB 
control number 0910-0231, which is the control number for the PMA 
process. As noted previously, FDA estimates that it will receive 12 new 
PMAs for AED devices and 21.5 for AED accessories as a result of this 
order, if finalized. Based on FDA's most recent estimates, this will 
result in 22,378 hours burden increase to OMB control number 0910-0231. 
FDA also estimates that there will be 3.4 fewer 510(k) submissions as a 
result of this order, if finalized. Based on FDA's most recent 
estimates, this will result in a 269 hours burden decrease to OMB 
control number 0910-0120. Therefore, on net, FDA expects a burden hour 
increase of

[[Page 17895]]

22,109 hours due to this proposed regulatory change.

IX. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become 
effective on the date of its publication in the Federal Register or at 
a later date if stated in the final order.

X. 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 approval of an 
application for premarket 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 
approval of an application for premarket 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 
an application for premarket approval, resulting from changes issued in 
a final order, in the Code of Federal Regulations (CFR). Therefore, 
under section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in 
this proposed order, we are proposing to require approval of an 
application for premarket approval for AEDs and if this proposed order 
is finalized, we will make the language in 21 CFR 870.5310 consistent 
with the final version of this proposed order.

XI. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XII. Reference

    The following reference has 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, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    1. The panel transcript and other meeting materials are available 
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm240575.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, it is 
proposed that 21 CFR part 870 be 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:

Sec.  870.5310  Automated external defibrillator system.

    (a) Identification. An automated external defibrillator (AED) 
system consists of an AED device and its accessories, i.e., battery, 
pad electrode and, if applicable, an adapter. 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 is 
required to be submitted to the Food and Drug Administration by [A DATE 
WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER 
IN THE FEDERAL REGISTER], for any automated external defibrillator that 
was in commercial distribution before May 28, 1976, or that has, by [A 
DATE WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL 
ORDER IN THE FEDERAL REGISTER], been found to be substantially 
equivalent to any automated external defibrillator that was in 
commercial distribution before May 28, 1976. Any other automated 
external defibrillator and automated external defibrillator 
accessories, i.e., pad electrodes, adaptors, and batteries shall have 
an approved PMA or declared completed PDP in effect before being placed 
in commercial distribution.

    Dated: March 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06723 Filed 3-22-13; 8:45 am]
BILLING CODE 4160-01-P