FDA Posts Updated Guidance on Medical Device Unique Identifier Formats
The Food and Drug Administration on May 8 posted to its website two updated guidance documents intended to assist with compliance with the agency’s new requirements for unique device identifiers (UDIs) on the labels of medical devices and device packages.…
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Under FDA’s September 2013 final rule, the UDI system will be phased in over a seven year period, with marking of class III devices required by September 2014, class II devices by 2016, and class I and all other devices by 2018 (and for reusable devices, on the class I device itself by 2020) (see 13092020). The "GUDID Data Elements Reference Table: (here) summarizes device attribute information that will populate the Global Unique Device Identification Database (GUDID). “UDI Formats by FDA-Accredited Issuing Agency” (here) summarizes the UDI formats for the issuing agencies that FDA has accredited to date.