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FDA Issues Guidance on Unique Device Identification System
July 26, 2016
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The FDA announced the availability of the draft guidance for industry and FDA staff in a Federal Register Notice (FRN) entitled “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)”on July 26, 2016. 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 This draft guidance is not the final version of the guidance nor is it in effect at this time.
 

Read the full notice on the Federal Register: Unique Device Identification System: Form and Content of the Unique Device Identifier; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments