A Practical Guide to Medical Device Labeling and UDI
Labeling requirements for medical devices, including unique device identifiers.
Priya Raghunathan
Why does it matter?
Device labels carry mandatory content, and identifiers must appear in a specified format for traceability.
What are the numbers?
- Unique Device Identification devices generally require a unique identifier on labels
- Mandatory content labels must include specified information
- Symbols standardized symbols may be used with explanation
- Changes label changes need regulatory review
What should I do?
- Confirm labeling requirements before design
- Include identifiers in the required formats
- Leave room for mandatory content
- Have labels reviewed by regulatory staff
- Control label versions carefully
What should I avoid?
Avoid:
- Design-led labels that omit required content
- Identifiers in non-compliant formats
- Symbols without explanation
- Label changes made without review
When should I get help?
Short answer Bring in help before producing device packaging.
Where this comes from
- U.S. Food and Drug Administration — Unique Device Identification
- U.S. Food and Drug Administration — Medical device advertising and promotion
The figures and practices above come from the sources listed.
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