FDA finalizes long-awaited UDI guidance

The US Food and Drug Administration (FDA) has now finalized its guidance on requirements for unique device identifiers (UDI), nearly five years after releasing its draft guidance and eight years after issuing the UDI final rule.

FDA said the final guidance is intended to describe “the requirements for, and FDA’s recommendations regarding, the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule,” and is aimed at labelers and FDA-accredited issuing agencies.

The guidance itself provides a description of the two forms of a UDI, which include the easily readable plain-text form and the automatic identification and data capture (AIDC) technology form, and discusses the use of data delimiters and the order that data should be presented in the easily readable plain-text form of the UDI carrier.

The final guidance includes clarifications on the agency’s expectations for the forms and content of UDI throughout, and also now includes a figure providing an example of a UDI in both easily readable plain-text and AIDC forms, along with other non-UDI label information.

While the final guidance has been revised from the draft version in response to comments, FDA has rebuffed industry’s requests for several changes to the document, including as they relate to data delimiters and FDA’s recommendations on the order of data represented in the easily readable plain-text form.