Notice2022-20512
Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
September 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 183 (Thursday, September 22, 2022)</title>
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[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57910-57912]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="https://www.fda.gov/media/102699/download">https://www.fda.gov/media/102699/download</a>.
\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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-medical-devices-electronic-format-submissions-under-section-745ab</a>.
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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
[[Page 57912]]
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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``Electronic Submission Template for Medical Device 510(k)
Submissions'' may send an email request to <a href="/cdn-cgi/l/email-protection#91d2d5c3d9bcd6e4f8f5f0fff2f4d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="367572647e1b71435f525758555376505257185e5e4518515940">[email protected]</span></a> 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
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