[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42864-42867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15250]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3769]


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; 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 ``Providing Regulatory 
Submissions for Medical Devices in Electronic Format--Submissions Under 
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' 
Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by 
the FDA Reauthorization Act of 2017 (FDARA) require that certain pre-
submissions and submissions for devices be submitted in

[[Page 42865]]

electronic format specified by FDA beginning on such date as specified 
in final guidance. It also mandates that FDA issue draft guidance not 
later than October 1, 2019, and a final guidance not later than 1 year 
after the close of the public comment period, 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 from 
the Secretary of Health and Human Services to Congress, FDA committed 
to developing electronic submission templates, and issuing a draft 
guidance on the topic. No later than 12 months after the close of the 
public comment period, the Agency will issue a final guidance. This 
guidance is intended to satisfy the final guidance documents referenced 
in the FDA&C Act and the MDUFA IV Commitment Letter.

DATES: The announcement of the guidance is published in the Federal 
Register on July 15, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidance documents 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-2019-D-3769 for ``Providing Regulatory Submissions for Medical 
Devices in Electronic Format--Submissions Under Section 745A(b) of the 
Federal Food, Drug, and Cosmetic Act.'' 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 (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 
``Providing Regulatory Submissions for Medical Devices in Electronic 
Format--Submissions Under Section 745A(b) of the Federal Food, Drug, 
and Cosmetic Act'' 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, MD 20993-0002, or to the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research (CBER), 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: Jacqueline Gertz, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993-0002, 240-
402-9677 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 FD&C Act (21 U.S.C. 379k-1(b)), amended by 
section 207 of FDARA (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 (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

[[Page 42866]]

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 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.'' No later than 12 
months after the close of the public comment period, the Agency will 
issue a final guidance. This guidance is intended to satisfy the final 
guidance documents referenced in section 745A(b)(3) of the FD&C Act and 
the MDUFA IV Commitment Letter.
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    \1\ https://www.fda.gov/media/102699/download.
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    The Agency has 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, this 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. Specifically, this guidance discusses: (1) The 
submission types that must be submitted electronically, (2) criteria 
for waivers of and exemptions from the submissions in electronic format 
requirements, and (3) the timetable and process for implementing the 
requirements.
    A notice of availability for the draft guidance appeared in the 
Federal Register of November 25, 2019 (84 FR 50850). FDA considered the 
comments received and revised the guidance as appropriate in response 
to the comments, including an update to add real-time review Premarket 
approval application (PMA) supplements and a clarification that we 
intend to consider the time period necessary to transition to use of 
the electronic format when identifying the date on which electronic 
format 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 document 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).)
    However, this document also contains guidance on additional 
submission types for which submission in electronic format is not 
required. To the extent that this guidance describes recommendations 
that are not standards, timetable, criteria for waivers of, or 
exemptions under section 745A(b)(3), it is being issued in accordance 
with FDA's good guidance practices regulation (Sec.  10.115). This 
guidance represents the Agency's current thinking on this topic, and do 
not create or confer any rights for or on any person and do not operate 
to bind FDA or the public. An alternative approach may be used for 
these recommendations if such an approach 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 is also available at 
https://www.regulations.gov or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download an electronic copy of 
``Providing Regulatory Submissions for Medical Devices in Electronic 
Format--Submissions Under Section 745A(b) of the Federal Food, Drug, 
and Cosmetic Act'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 19031 to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 
the following FDA regulations and guidances have been approved by OMB 
as listed in the following table:

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                                                            OMB control
    21 CFR part or guidance               Topic                 No.
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807, subpart E.................  Premarket Notification        0910-0120
                                  Submission.
814, subparts A through E......  Premarket Approval            0910-0231
                                  Application.
814, subpart H.................  Humanitarian Use Device       0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo Classification        0910-0844
 Process (Evaluation of           Process.
 Automatic Class III
 Designation)''.
``FDA and Industry Procedures    513(g) Request for            0910-0705
 for Section 513(g) Requests      Information.
 for Information under the
 Federal Food, Drug, and
 Cosmetic Act''.
``Requests for Feedback on       Pre-Submissions........       0910-0756
 Medical Device Submissions:
 The Q-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.

[[Page 42867]]

 
``Humanitarian Device Exemption  Humanitarian Device           0910-0661
 Regulation: Q&As''.              Exemption Applications
                                  and Annual
                                  Distribution Number
                                  Reporting Requirements.
``Emergency Use Authorization    Emergency Use                 0910-0595
 of Medical Products''.           Authorization.
601............................  Biologics License             0910-0338
                                  Applications.
``Recommendations for Clinical   CLIA Waiver                   0910-0598
 Laboratory Improvement           Applications.
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
``Administrative Procedures for  Administrative                0910-0607
 Clinical Laboratory              Procedures for CLIA
 Improvement Amendments of 1988   Categorizations.
 Categorization''.
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    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15250 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P