[Federal Register Volume 90, Number 219 (Monday, November 17, 2025)]
[Notices]
[Pages 51371-51373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19948]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-5107]
Menstrual Products--Performance Testing and Labeling
Recommendations; Draft Guidance for Industry and Food and Drug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the availability of the draft guidance entitled ``Menstrual Products--
Performance Testing and Labeling Recommendations.'' This draft guidance
document provides recommendations for performance testing, labeling,
and information for inclusion in premarket notification (510(k))
submissions, when necessary, for certain menstrual products. The
recommendations in this guidance apply to tampons, pads, and menstrual
cups used to absorb or collect menstrual fluid or other vaginal
discharge. The recommendations reflect updated review practices and are
intended to promote consistency and transparency in product labeling
and testing for manufacturers of these devices. This draft guidance is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DATES: Submit either electronic or written comments on the draft
guidance by January 16, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
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-2025-D-5107 for ``Menstrual Products--Performance Testing and
Labeling Recommendations.'' 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
[[Page 51372]]
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
``Menstrual Products--Performance Testing and Labeling
Recommendations'' 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.
SUPPLEMENTARY INFORMATION:
I. Background
In appropriations reports from the House Appropriations Committee
in the fiscal years 2022 and 2023, the Committee requested that FDA
update its guidance on menstrual tampons and pads, ``Menstrual Tampons
and Pads: Information for Premarket Notification Submissions
(510(k)s),'' issued on July 27, 2005. This draft guidance, which when
final will supersede, ``Menstrual Tampons and Pads: Information for
Premarket Notification Submissions (510(k)s),'' includes information
requested by the Committee in the appropriations reports and provides
additional detail and clarifications to existing recommendations.
Specifically, the draft guidance includes recommendations for menstrual
cups, disclosing ingredients (including fragrances/deodorants) on all
menstrual product outer package labels, evaluating contaminants for all
menstrual products, test methods that can be used for evaluating
tampons for Toxic Shock Syndrome risk and effect on vaginal microflora,
and clarification of test methods for non-clinical bench testing of
tampons.\1\
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\1\ FDA supports the principles of the ``3Rs'' to replace,
reduce, and/or refine animal use in testing, when feasible. We
encourage manufacturers to consult with FDA if they wish to use a
non-animal testing method that they believe is suitable, adequate,
validated, and feasible. We will consider if a proposed alternative
method could be assessed for equivalency to an animal test method.
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This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on Menstrual
Products--Performance Testing and Labeling Recommendations and will
supersede ``Menstrual Tampons and Pads: Information for Premarket
Notification Submissions (510(k))s,'' issued on July 27, 2005. 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 any 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 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. Persons unable to
download an electronic copy of ``Menstrual Products--Performance
Testing and Labeling Recommendations'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number GUI00000166 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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OMB control
21 CFR part; guidance; or FDA form Topic No.
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807, subpart E.................... Premarket 0910-0120
notification.
812............................... Investigational 0910-0078
Device Exemption.
``Requests for Feedback and Q-submissions and 0910-0756
Meetings for Medical Device Early Payor
Submissions: The Q-Submission Feedback Request
Program''. Programs for
Medical Devices.
800, 801, 809, and 830............ Medical Device 0910-0485
Labeling
Regulations; Unique
Device
Identification.
820............................... Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System (QS)
Regulation.
50, 56............................ Protection of Human 0910-0130
Subjects and
Institutional
Review Boards.
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[[Page 51373]]
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-19948 Filed 11-14-25; 8:45 am]
BILLING CODE 4164-01-P