[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Pages 53965-53967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21135]



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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Submissions; Draft Guidance for Industry and Food and Drug 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the availability of the draft guidance entitled ``Electronic Submission 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draft guidance to introduce submitters of premarket notification 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 This draft guidance, when finalized, is intended to 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 This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by November 29, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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

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(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\ 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. 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 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/biologics-guidances. 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, 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:
     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?
     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