The Food and Drug Administration on Dec. 26 named the Health Industry Business Communications Council, a standards development organization, as the second accredited issuing agency for unique device identifiers for medical devices.
FDA a week earlier selected standards firm GS1 as the first accredited issuing agency and more accreditors could be named. The action comes following publication in September 2013 of a final rule to establish the identifier after legislation was enacted in 2007. The rule sets compliance dates for specific milestones each September from 2014 through 2020.
In general, the final rule requires the label on medical devices to include a UDI, with some exceptions or alternative placement depending on characteristics of a device. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology, according to the final rule. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
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