This draft guidance is intended to assist both labelers and FDA-accredited IAs better ensure the UDIs developed under IA systems are in compliance with the UDI rule. It includes clarification on:
Two forms of a UDI;
Content of the UDI (including data delimiters that identify specific data elements within the UDI); and
Order of data in a UDI and UDI carrier (the means to convey the UDI and any non-UDI elements in easily readable plain-text and AIDC forms).