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
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