[Federal Register Volume 90, Number 121 (Thursday, June 26, 2025)]
[Notices]
[Pages 27310-27312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11806]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-0176]
Unique Device Identifier Requirements for Combination Products;
Draft Guidance for Industry and FDA Staff; Availability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the availability of a draft guidance for industry and FDA staff
entitled ``Unique Device Identifier (UDI) Requirements for Combination
Products.'' This draft guidance is intended to assist industry and FDA
staff in understanding how FDA's unique device identifier (UDI)
requirements apply to combination products with device constituent
parts.
DATES: Submit either electronic or written comments on the draft
guidance by September 24, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 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'').
[[Page 27311]]
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-0176 for ``Unique Device Identifier (UDI) Requirements for
Combination Products.'' 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)).
Submit written requests for single copies of the draft guidance to
the to the Office of Combination Products, Food and Drug
Administration, Bldg. 32, Rm. 5129, 10903 New Hampshire Ave. Silver
Spring, MD 20993. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Stephanie Shapley, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave. Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-4836,
[email protected] or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Unique Device Identifier (UDI) Requirements
for Combination Products.'' A combination product is comprised of two
or more different types of products (i.e., a combination of a drug,
device, and/or biological product with one another). Each drug, device,
and biological product included in a combination product is referred to
as a ``constituent part'' of the combination product (see 21 CFR 3.2).
The final rule entitled ``Unique Device Identification System'' (UDI
Rule), establishing the unique device identification system, published
on September 24, 2013 (78 FR 58786). The UDI Rule requires that the
label and device package of every medical device bear a UDI, unless an
exception or alternative applies (see 21 CFR 801.20).
This draft guidance is intended to assist industry and FDA staff in
understanding how FDA's UDI requirements at 21 CFR part 801 subpart B
and part 830 subpart E apply to combination products with device
constituent parts. This draft guidance outlines the requirements,
recommendations, and best practices for UDI labeling and for submission
of information to the Global Unique Device Identification Database for
such combination products. This draft guidance also provides some
hypothetical examples to illustrate how UDI requirements can be met for
combination products.
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 ``Unique
Device Identifier (UDI) Requirements for Combination Products.'' 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. Other Issues for Consideration
The draft guidance acknowledges that for some co-packaged
combination products that properly bear a National Drug Code, labelers
may be able to identify each device constituent part based on
information captured in the product identifier and the combination
product's quality system (e.g., the device version or model number and
device lot/batch for each device). FDA requests public comment on the
statement in the draft guidance that FDA is considering what approach
or approaches to take in these circumstances for types of device
constituent parts in such combination products. See section III.B. of
the draft guidance.
III. Paperwork Reduction Act of 1995
While this guidance contains no 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 21 CFR part 801 subpart B and 21 CFR part 830 have been approved
under OMB control number 0910-0485.
IV. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
[[Page 27312]]
Dated: June 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11806 Filed 6-25-25; 8:45 am]
BILLING CODE 4164-01-P