Unique Device Identification System: Form and Content of the Unique Device Identifier; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' When finalized, this draft document will define the expected content and forms of the unique device identifier (UDI), to assist both labelers and FDA-accredited issuing agencies better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the unique device identification system rule (UDI Rule). This draft guidance is not the final version of the guidance nor is it in effect at this time.