FDA Posts Draft Guidance on Unique Device Identifier Format
The Food and Drug Administration issued a draft guidance document outlining format requirements for unique device identifiers, it said in a notice (here). The draft guidance, “Unique Device Identification System: Form and Content of the Unique Device Identifier” (here), describes…
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“the two forms of a UDI,” clarifies the content of the UDI, and discusses “the order of the data in a UDI and UDI carrier.” FDA’s UDI rule started taking effect in September 2014 (see 13092020). The next effective date is Sept. 24, 2016, when FDA will require UDIs on the labels and packages of class II devices, data submissions for class II devices, and direct marking of certain class III devices, according to the FDA website (here).