At the end of July 2016, FDA announced the availability of a draft guidance titled "Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)," which clarifies the requirements for unique device identifiers on medical devices, as established in 2013 with publication of the UDI System final rule. The guidance document further defines the two forms of UDI labeling (plain-text and automatic identification and data capture, "AIDC") and clarifies how UDI information should be ordered and presented on device packaging. According to the guidance, plain-text UDIs should be legible interpretations of the data characters encoded in the AIDC form of the full UDI and should be located near the AIDC form of the UDI on devices. Such plain-text versions of UDIs should include device and production information, as well as data delimiters—a defined set of characters that identifies specific data elements within the UDI. The AIDC form of the UDI should be in a format that can be read by a bar code scanner or similar AIDC technology, and the guidance encourages scanning of UDIs whenever possible to minimize errors and allow for "rapid and accurate data acquisition, recording, and retrieval." The guidance document declines to recommend how labelers should disclose the presence of AIDC technology that is not evident upon visual examination, giving flexibility and discretion to labelers. Comments on the draft guidance are due September 26, 2016.
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