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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
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All written comments should be identified with this document's docket number: FDA-2025-D-0176
- Docket Number:
- FDA-2025-D-0176
- Issued by:
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Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
This document is intended to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements at 21 CFR part 801 subpart B and part 830 subpart E apply to combination products with device constituent parts. This guidance outlines the requirements, recommendations, and best practices for UDI labeling and for submission of information to the Global Unique Device Identification Database (GUDID) for such combination products. This guidance also provides hypothetical examples to illustrate how UDI requirements can be met for these combination products.
