FDA Drafts Rules for Combo Product Unique ID Labels
Published Date: 6/26/2025
Notice
Summary
The FDA just dropped a draft guide to help companies understand how to label combo products with unique device IDs. If you make products that mix drugs and devices, this affects you and helps keep things clear and safe. No big money changes yet, but get ready to follow these new labeling rules soon!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Draft UDI Guidance for Combination Products
The FDA announced a draft guidance titled "Unique Device Identifier (UDI) Requirements for Combination Products" to help industry and FDA staff understand how UDI requirements apply to combination products with device constituent parts. If you make combination drug-and-device products, this guidance explains how FDA expects those products to be labeled under the UDI system.
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