Notice2026-19181
Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
September 18, 2026
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)." FDA is issuing this draft guidance for submitters of certain PMAs to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those submitters to the current publicly available resources and associated content developed to support electronic submissions of certain PMAs and PMA supplements 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 This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as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 This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 91 Issue 180 (Friday, September 18, 2026)</title>
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[Federal Register Volume 91, Number 180 (Friday, September 18, 2026)]
[Notices]
[Pages 59138-59140]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19181]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-D-9429]
Electronic Submission Template for Medical Device Premarket
Approval Applications (PMAs); Draft Guidance for Industry and Food and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the availability of the draft guidance entitled ``Electronic Submission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 Premarket Approval Applications (PMAs).''
FDA is issuing this draft guidance for submitters of certain PMAs to
the Center for Devices and Radiological Health (CDRH) and Center for
Biologics Evaluation and Research (CBER). It introduces those
submitters to the current publicly available resources and associated
content developed to support electronic submissions of certain PMAs and
PMA supplements 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 for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by November 17, 2026 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-2026-D-9429 for ``Electronic Submission Template for Medical Device
Premarket Approval Applications (PMAs).'' 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.
[[Page 59139]]
<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 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 Premarket Approval
Applications (PMAs)'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 301-796-6353; or
Phillip Kurs, Center for Biologics Evaluation and Research, Food and
Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this draft guidance document to introduce submitters
of certain PMAs to CDRH and CBER to the current resources and
associated content developed and made publicly available to support
electronic submissions of certain PMAs/PMA supplements to FDA. These
include Original PMAs, Panel-Track Supplements, 180-day Supplements,
Real Time Supplements, and 30-Day Notices/135-Day Supplements. This
draft 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.
When finalized, this guidance will also facilitate the implementation
of the FDA's mandate under 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 (FDARA) (Pub. L. 115-52), to
provide 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.
FDA's final guidance document published on July 15, 2020 (85 FR
42864): ``Providing Regulatory Submissions for Medical Devices in
Electronic Format--Submissions Under Section 745A(b) of the Federal
Food, Drug, and Cosmetic Act'' (hereafter referred to as the ``745A(b)
device parent guidance'') provides a process for the development of
templates to facilitate the preparation, submission, and review of
regulatory submissions for medical devices solely in electronic format.
As described in the 745A(b) device parent guidance, FDA plans to
implement the requirements of section 745A(b)(3) of the FD&C Act with
individual guidances specifying the formats for specific submissions
and corresponding timetables for implementation. When finalized, this
guidance will provide such information for electronic submissions of
certain PMAs/PMA supplements solely in electronic format.
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 consistent with
FDA's good guidance practices regulation (Sec. 10.115).
The draft guidance, when finalized, will represent the current
thinking of FDA on Electronic Submission Template for PMAs/PMA
supplements. 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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
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">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 Premarket Approval
Applications (PMAs)'' may send an email request to <a href="/cdn-cgi/l/email-protection#3c7f786e74117b4955585d525f597c5a585d1254544f125b534a"><span class="__cf_email__" data-cfemail="4e0d0a1c0663093b272a2f202d2b0e282a2f6026263d60292138">[email protected]</span></a> to receive an electronic
[[Page 59140]]
copy of the document. Please use the document number GUI00007079 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
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21 CFR part Topic OMB control No.
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814, subparts A through E..... Premarket approval... 0910-0231
800, 801, 809, and 830........ Medical Device 0910-0485
Labeling
Regulations; Unique
Device
Identification.
820........................... Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality Management
System Regulation
(QMSR).
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19181 Filed 9-17-26; 8:45 am]
BILLING CODE 4164-01-P
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