[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 It also mandates that FDA issue draft guidance not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to developing electronic submission templates, and issuing a draft
guidance on the topic.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.
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``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