[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68344-68345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1877]


Necessary Automated External Defibrillator Accessories: Policy 
Regarding Compliance Date; Immediately in Effect Guidance for Industry, 
Stakeholders, Health Care Professionals, and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Necessary Automated 
External Defibrillator Accessories: Policy Regarding Compliance Date.'' 
FDA is issuing this guidance to revise its compliance policy regarding 
the deadline for filing premarket approval (PMA) applications for 
previously cleared accessories necessary to the operation of automated 
external defibrillator (AED) systems.

DATES: The announcement of the guidance is published in the Federal 
Register on October 28, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-D-1877 for ``Necessary Automated External Defibrillator 
Accessories: Policy Regarding Compliance Date.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Necessary Automated External Defibrillator Accessories: Policy 
Regarding Compliance Date'' to the Office of Policy, Guidance and 
Policy Development, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring,

[[Page 68345]]

MD 20993-0002. Send one self-addressed adhesive label to assist that 
office in processing your request.

FOR FURTHER INFORMATION CONTACT: Jessica Paulsen, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2108, Silver Spring, MD 20993-0002, 301-
796-6883.

SUPPLEMENTARY INFORMATION:

I. Background

    In February 2015, FDA published a final order requiring the 
submission of premarket approval (PMA) applications for new and 
existing AEDs and necessary AED accessories. The final order required 
the submission of a PMA application for any preamendments and 
substantially equivalent AED necessary accessory--such as batteries, 
pad electrodes, adapters, and hardware keys for pediatric use--within 
90 days of the date of the final order; however, the final order also 
stated that FDA did not intend to enforce compliance with the PMA 
submission requirement for these necessary AED accessories for 60 
months following the date of the final order, which was February 3, 
2020.
    For the reasons described in the guidance, at this time FDA does 
not intend to enforce compliance with the PMA submission requirement 
for these necessary AED accessories until February 3, 2022.
    This guidance is being implemented without prior public comment 
because the Agency has determined that prior public participation is 
not feasible or appropriate (see section 701(h)(1)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 
10.115(g)(2)). FDA has determined that this guidance document presents 
a less burdensome policy that is consistent with public health. 
Although this guidance is immediately in effect, FDA will consider all 
comments received and revise the guidance document as appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Necessary Automated External Defibrillator 
Accessories: Policy Regarding Compliance Date. It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov. Persons unable to download an 
electronic copy of ``Necessary Automated External Defibrillator 
Accessories: Policy Regarding Compliance Date'' may send an email 
request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of 
the document. Please use the document number 20043 and complete title 
to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required 
for this guidance. The previously approved collections of information 
are subject to review by OMB under the PRA. The collection of 
information in the following FDA regulations have been approved by OMB 
as listed in the following table:

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                                                            OMB control
          21 CFR part                     Topic                 No.
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814, subparts A through E......  Premarket approval.....       0910-0231
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    Dated: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23841 Filed 10-27-20; 8:45 am]
BILLING CODE 4164-01-P


