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Guidance on Unique Device ID System


Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The draft document will define the expected content and forms of the 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). To download this guidance, click here. To view this notice, click here.