The UDI rule
AIDC + HRI on every label and package, UDI-PI on the device for Class III, GUDID submissions, and the accredited issuing agencies.
Free field guide · PDF
FDA UDI & Labeling2026 Field Guide
The UDI rule, the label content, and the kit trap — with the labeling practice you need.
- UDI form
- AIDC+HRI
- Date format
- YYYY-MM-DD
- 801 amendments
- Dec 2025
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The label content
801.1 responsible-firm wording, directions for use, warnings, OTC identity, the YYYY-MM-DD date format, and 820.45 procedures under QMSR.
The kit trap
The 801.30(a)(11) convenience-kit exception, the December 2025 technical amendments, and who counts as the labeler.
Sources & scope
- informait.com, UDI Labeling Requirements: What Medical Device Manufacturers Need on Every Label.
- kbmed.com, Regulatory Insights: What Medical Device Manufacturers Should Know About U.S. Labeling.
- meddeviceguide.com, Medical Device Kits: Who Assembles, Labels, and Takes Responsibility?
This guide is market-access intelligence, not regulatory or legal advice. Labeling requirements, UDI practice, and enforcement change — professional review is required before business use.
Market Access Strategy Session
US labeling on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your labeling strategy — UDI compliance, label content, and kit structuring.
Professional review is required before business use.
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