The Food and Drug Administration has named supply chain standards development organization GS1 as the first accredited issuing agency for unique device identifiers for medical devices.
Six years after legislation was enacted to establish an identifier, FDA in September 2013 issued a final rule. It includes compliance dates each September from 2014 through 2020 to implement provisions of the law.
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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