Notice2025-10275
Hernia Mesh-Package Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
June 6, 2025
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Hernia Mesh--Package Labeling Recommendations." This draft guidance provides labeling recommendations for hernia mesh devices that are intended to help promote the safe and effective use of hernia mesh. This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 90 Issue 108 (Friday, June 6, 2025)</title>
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[Federal Register Volume 90, Number 108 (Friday, June 6, 2025)]
[Notices]
[Pages 24144-24146]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10275]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-1150]
Hernia Mesh--Package Labeling Recommendations; Draft Guidance for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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[[Page 24145]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Hernia Mesh--Package
Labeling Recommendations.'' This draft guidance provides labeling
recommendations for hernia mesh devices that are intended to help
promote the safe and effective use of hernia mesh. This draft guidance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DATES: Submit either electronic or written comments on the draft
guidance by August 5, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
<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-2025-D-1150 for ``Hernia Mesh--Package Labeling Recommendations.''
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.
<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
``Hernia Mesh--Package 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: Nils Potter, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4526, Silver Spring, MD 20993-0002, 240-402-7130.
SUPPLEMENTARY INFORMATION:
I. Background
Hernia meshes represent a diverse group of medical devices intended
for hernia repair in different anatomic regions and featuring a wide
variety of physical and mechanical properties. The range of hernia mesh
characteristics and properties can make it challenging, even for
experienced healthcare providers, to choose the most appropriate hernia
mesh for a given patient, while also taking into consideration patient-
specific factors and surgical approach. Since January 1, 2019, FDA has
received over 86,000 adverse event reports related to hernia mesh. The
package labeling recommendations in this draft guidance are intended to
help promote the safe and effective use of hernia mesh. In particular,
the package labeling recommendations may provide for a more consistent
format for disseminating certain clinically relevant information,
making it easier for healthcare providers to find certain information
needed to use these devices safely and for the purposes for which they
are intended.
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 Hernia Mesh--
Package Labeling Recommendations. 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 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
[[Page 24146]]
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>. Persons unable to
download an electronic copy of ``Hernia Mesh--Package Labeling
Recommendations'' may send an email request to <a href="/cdn-cgi/l/email-protection#d79493859ffa90a2beb3b6b9b4b297b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="652621372d4822100c01040b0600250301044b0d0d164b020a13">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number GUI00007030 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 or guidance Topic OMB control No.
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807, subpart E.......................... Premarket notification............................. 0910-0120
800, 801, 809, and 830.................. Medical Device Labeling Regulations; Unique Device 0910-0485
Identification.
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Dated: June 2, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10275 Filed 6-5-25; 8:45 am]
BILLING CODE 4164-01-P
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