Notice2021-21135
Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
September 29, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device 510(k) Submissions." FDA is issuing this draft guidance to introduce submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed to support 510(k) electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as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 This draft guidance is not final nor is it in effect at this time.
Full Text
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<title>Federal Register, Volume 86 Issue 186 (Wednesday, September 29, 2021)</title>
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[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Pages 53965-53967]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21135]
[[Page 53965]]
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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Submissions; Draft Guidance for Industry and Food and Drug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the availability of the draft guidance entitled ``Electronic Submission
Template for Medical Device 510(k) Submissions.'' FDA is issuing this
draft guidance to introduce submitters of premarket notification
(510(k)) submissions to the Center for Devices and Radiological Health
and Center for Biologics Evaluation and Research to the current
resources and associated content developed to support 510(k) electronic
submissions to FDA. This draft guidance, when finalized, 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 draft
guidance is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by November 29, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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 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 draft 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; or Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 pre-
submissions 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
[[Page 53966]]
(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 pre-submissions 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 ``by 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\ <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. The current draft guidance
``Electronic Submission Template for Medical Device 510(k)
Submissions'' is the first of these individual guidances that, when
finalized, will specify the format for 510(k) submissions and a
corresponding timetable for implementation.
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 draft 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 draft 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 draft guidance, when finalized, will represent 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 draft guidance, when finalized, will
contain both binding and nonbinding provisions.
II. Electronic Access
Persons interested in obtaining a copy of the draft 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/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</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#185b5c4a50355f6d717c79767b7d587e7c793670706b367f776e"><span class="__cf_email__" data-cfemail="fcbfb8aeb4d1bb8995989d929f99bc9a989dd294948fd29b938a">[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, guidance, and forms
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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801 and 809.................... Medical Device Labeling 0910-0485
Regulations.
807, subpart E, including forms Premarket Notification 0910-0120
FDA 4062 ``Electronic Submission, including
Submission Template and submissions via eSTAR.
Resource (eSTAR)'' and FDA
4078 ``Electronic Submission
Template and Resource
(eSTAR)'' (for In Vitro
Diagnostic (IVD) 510(k)
submissions).
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IV. Other Issues for Consideration
The Agency invites comments on the ``Electronic Submission Template
for Medical Device 510(k) Submissions'' draft guidance, in general, and
on the following questions, in particular:
<bullet> Is a minimum of 1 year an adequate amount of time to
transition to submissions solely in electronic format for 510(k)
submissions using the eSTAR template?
<bullet> If a minimum of 1 year is not adequate, how much time
would be necessary for you to transition to use of eSTAR as the
required format for 510(k) submission?
Dated: September 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21135 Filed 9-28-21; 8:45 am]
BILLING CODE 4164-01-P
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