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UDI Labelling Requirements

What must appear on the label​

Under 21 CFR § 830.20, device labels must include the UDI in:

  1. Human-readable form — the DI (and PI where applicable) in plain text that can be read by a person
  2. AIDC (Automatic Identification and Data Capture) format — typically a barcode or 2D matrix code

The AIDC must encode the full UDI (DI + applicable PI elements).

Packaging levels​

UDI labelling requirements apply at the individual device (base package) level and, where applicable, at higher-level packaging (case, pallet). Each packaging level typically has its own UDI.

Exceptions and alternatives​

  • Small devices: Where the label is too small to accommodate a barcode, FDA may permit alternative approaches (e.g., direct part marking or a reference to the UDI in the IFU)
  • Direct part marking: For reusable devices (e.g., surgical instruments), the UDI must be directly marked on the device itself in addition to the label

Official resources​