[Federal Register Volume 90, Number 102 (Thursday, May 29, 2025)]
[Notices]
[Pages 22742-22744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09615]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-1082]
Electronic Submission Template for Medical Device Q-Submissions;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Electronic Submission
Template for Medical Device Q-Submissions.'' FDA is issuing this draft
guidance to introduce submitters of certain Q-Submissions (Q-Subs),
specifically Pre-Submissions (Pre-subs) to the Center for Devices and
Radiological Health (CDRH) and Center for Biologics Evaluation and
Research (CBER), to the current resources and associated content
developed and made publicly available to support Pre-Sub 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 This draft guidance, when finalized, is intended to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 This draft
guidance is not final nor is it for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by July 28, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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
[[Page 22743]]
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-2025-D-1082 for ``Electronic Submission Template for Medical Device
Q-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 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 Q-Submissions'' 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, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353;
or James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this draft guidance document to introduce submitters
of Pre-Subs to CDRH and CBER to the current resources and associated
content developed and made publicly available to support Pre-Sub
electronic submissions to FDA. 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 guidance document ``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 Pre-Sub
electronic submissions 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 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
[[Page 22744]]
the requirements of the applicable statutes and regulations. This draft
guidance, when finalized, will contain both binding and nonbinding
provisions.
As we develop any final guidance on this topic, FDA will consider
comments on the applicability of Executive Order 14192, per OMB
guidance M-25-20, and in particular, on any costs or cost savings.
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. Persons unable to download an electronic copy of
``Electronic Submission Template for Medical Device Q-Submissions'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number
GUI00007041 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:
------------------------------------------------------------------------
21 CFR part; guidance; or FDA OMB control
Form Topic No.
------------------------------------------------------------------------
``Requests for Feedback and Q-submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
------------------------------------------------------------------------
Dated: May 22, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09615 Filed 5-28-25; 8:45 am]
BILLING CODE 4164-01-P