[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57910-57912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0872]


Electronic Submission Template for Medical Device 510(k) 
Submissions; Guidance for Industry 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 ``Electronic Submission 
Template for Medical Device 510(k) Submissions.'' This final guidance 
is intended to represent one of several steps in meeting FDA's 
commitment to the development of electronic submission templates to 
serve as guided submission preparation tools for industry to improve 
submission consistency and enhance efficiency in the review process. 
This guidance document provides further standards for the submission of 
510(k)s by electronic format, a timetable for establishment of these 
further standards, and criteria for waivers of and exemptions from the 
requirements.

DATES: The announcement of the guidance is published in the Federal 
Register on September 22, 2022.

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

[[Page 57911]]

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-2021-D-0872 for ``Electronic Submission Template for Medical Device 
510(k) Submissions.'' 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 Sec.  
10.115(g)(5) (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 
``Electronic Submission Template for Medical Device 510(k) 
Submissions'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527; 
or Stephen Ripley, Center for Biologics Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 379k-1(b)), amended by section 207 of the FDA 
Reauthorization Act of 2017 (Pub. L. 115-52), requires that 
presubmissions and submissions for devices under section 510(k), 
513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the 
FD&C Act (21 U.S.C. 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 
360j(g), 360j(m), or 360bbb-3) or section 351 of the Public Health 
Service Act (42 U.S.C. 262) and any supplements to such presubmissions 
or submissions, including appeals of those submissions, be submitted in 
electronic format specified by FDA beginning on such date as specified 
by FDA in final guidance. It also mandates that FDA issue a draft 
guidance not later than October 1, 2019, providing for further 
standards for the submission by electronic format, a timetable for 
establishment of these further standards, and criteria for waivers of 
and exemptions from the requirements.
    In addition, in the Medical Device User Fee Amendments of 2017 
(MDUFA IV) Commitment Letter \1\ from the Secretary of Health and Human 
Services to Congress, FDA committed to developing ``electronic 
submission templates that will serve as guided submission preparation 
tools for industry to improve submission consistency and enhance 
efficiency in the review process'' and ``[b]y FY [fiscal year] 2020, 
the Agency will issue a draft guidance document on the use of the 
electronic submission templates.'' In addition, the Commitment Letter 
states that ``[n]o later than 12 months after the close of the public 
comment period, the Agency will issue a final guidance.'' FDA's 
guidance document ``Providing Regulatory Submissions for Medical 
Devices in Electronic Format--Submissions Under Section 745A(b) of the 
Federal Food, Drug, and Cosmetic Act'' issued July 15, 2020, (the 
``parent guidance'') \2\ was intended to satisfy the final guidance 
documents referenced in section 745A(b)(3) of the FD&C Act and the 
MDUFA IV Commitment Letter. A notice of availability of the parent 
guidance appeared in the Federal Register of July 15, 2020 (85 FR 
42864).
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    \1\ Available at: https://www.fda.gov/media/102699/download.
    \2\ ``Providing Regulatory Submissions for Medical Devices in 
Electronic Format--Submissions Under Section 745A(b) of the Federal 
Food, Drug, and Cosmetic Act; Guidance for Industry and Food and 
Drug Administration Staff'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab.
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    In the parent guidance, the Agency concluded that it is not 
feasible to describe and implement the electronic format(s) that would 
apply to all the submissions covered by section 745A(b) of the FD&C Act 
in one guidance document. Accordingly, the parent guidance describes 
how FDA interprets and plans to implement the requirements of section 
745A(b)(3) of the FD&C Act, while individual guidances will be 
developed to specify the formats for specific submissions and 
corresponding timetables for implementation.
    This final guidance ``Electronic Submission Template for Medical 
Device 510(k) Submissions'' is the first of these individual guidances 
that provides further standards for the submission of 510(k)s by 
electronic format, a timetable for establishment of these further 
standards, and criteria for waivers of and exemptions from the 
requirements. At this time, the electronic Submission Template And

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Resource (eSTAR) is the only electronic submission template available 
to prepare a complete 510(k) electronic submission using the guided 
prompts for the collection of structured and unstructured data.
    All 510(k) submissions, including original submissions for 
Traditional, Special, and Abbreviated 510(k)s, and subsequent 
Supplements and Amendments (amendments include add-to-files and 
appeals), and any other subsequent submissions to an original 
submission unless exempted in this final guidance, will be required to 
be submitted as electronic submissions as specified in the guidance. 
Section 745A(b)(2) of the FD&C Act allows for FDA to set forth criteria 
for exemptions and waivers from electronic submission requirements. FDA 
has identified such criteria in the final guidance document. FDA is 
identifying October 1, 2023, as the date on which the 510(k) electronic 
submission requirements will take effect.
    A notice of availability of the draft guidance appeared in the 
Federal Register of September 29, 2021 (86 FR 53965). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including updated criteria for exemptions; 
clarification of the technical screening hold; and description of the 
transition period and effective date on which 510(k) electronic 
submissions will be required.
    In section 745A(b) of the FD&C Act, Congress granted explicit 
statutory authorization to FDA to specify in guidance the statutory 
requirement for electronic submissions solely in electronic format by 
providing standards, a timetable, and criteria for waivers and 
exemptions. To the extent that this final guidance provides such 
requirements under section 745A(b)(3) of the FD&C Act (i.e., standards, 
timetable, criteria for waivers of and exemptions), indicated by the 
use of the mandatory words, such as must or required, this document is 
not subject to the usual restrictions in FDA's good guidance practice 
regulations, such as the requirement that guidances not establish 
legally enforceable responsibilities. (See Sec.  10.115(d).)
    To the extent that this final guidance describes recommendations 
that are not standards, timetable, criteria for waivers of, or 
exemptions under section 745A(b)(3) of the FD&C Act, it is being issued 
in accordance with FDA's good guidance practices regulation (Sec.  
10.115). This guidance represents the current thinking of FDA on this 
topic. 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. 
This final guidance contains both binding and nonbinding provisions.

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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Electronic Submission Template for Medical Device 510(k) 
Submissions'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 19006 and complete title to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (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 collections 
of information in the following FDA regulations and forms have been 
approved by OMB as listed in the following table:

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                                                            OMB control
    21 CFR part or FDA form               Topic                 No.
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807 subpart E, including forms   Premarket Notification        0910-0120
 FDA 4062 eSTAR and FDA 4078      Submission, including
 eSTAR (for In Vitro Diagnostic   submissions via eSTAR.
 (IVD) 510(k) submissions).
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
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    Dated: September 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20512 Filed 9-21-22; 8:45 am]
BILLING CODE 4164-01-P