US: UDI Labelling requirements guidance finalised

US FDA has published the finalised Labelling requirements guidance which assists labelers and FDA-accredited issuing agencies in complying with the UDI requirements.

USI Background:

- Intended to create a standardized identification system for identifying devices through distribution

- Each labeler must use one or more systems operated by an FDA accredited issuing agency to assign UDIs that appear on device labels

Guidance also includes:

- The forms of UDI

- AIDC

- Content of UDI

- Data delimiters (defined data character that identitied specific data elements within an encoded string in the

UDI carrier)

- D. Order of the data represented in the easily readable plain­text form of UDI carrier

- UDI for Stand-Alone Software

Source: https://www.fda.gov/media/99084/download

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