Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-D-0176]</DEPDOC> <SUBJECT>Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of availability. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Unique Device Identifier (UDI) Requirements for Combination Products.” This draft guidance is intended to assist industry and FDA staff in understanding how FDA's unique device identifier (UDI) requirements apply to combination products with device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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit either electronic or written comments on the draft guidance by September 24, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments on any guidance at any time as follows: <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> • 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”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> 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.” <E T="03">Instructions:</E> 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 <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> 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: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> 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 <E T="02">SUPPLEMENTARY INFORMATION</E> section for electronic access to the draft guidance document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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, <E T="03">stephanie.shapley@fda.hhs.gov</E> or <E T="03">combination@fda.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> 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 ( <E T="03">i.e.,</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. <HD SOURCE="HD1">II. Other Issues for Consideration</HD> 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 T="03">e.g.,</E> 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. <HD SOURCE="HD1">III. Paperwork Reduction Act of 1995</HD> 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. <HD SOURCE="HD1">IV. Electronic Access</HD> Persons with access to the internet may obtain the draft guidance at <E T="03">https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents, https://www.fda.gov/regulatory-information/search-fda-guidance-documents,</E> or <E T="03">https://www.regulations.gov.</E> <SIG> <DATED>Dated: June 23, 2025.</DATED> <NAME>Grace R. Graham,</NAME> Deputy Commissioner for Policy, Legislation, and International Affairs. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-11806 Filed 6-25-25; ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 10k characters. 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