Draft Guidance on UDI Form and Content

On July 26, 2016, FDA-CDRH released a draft guidance Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).

The guidance includes some definitions that are important, but not included in the UDI rule. These include Data Delimiter, Easily Readable Plain-Text, and UDI Carrier. It also reiterates the definition of Automatic Identification and Data Capture (AIDC) from the rule.

The manufacturer presents the UDI on the device label two forms, the AIDC and the Easily Readable Plain-Text. The draft guidance clarifies that the AIDC allows data entry into an electronic health record. The Easily Readable Plain-Text is a legible interpretation of the characters in the AIDC including the data delimiters.