Six years after authorizing legislation was enacted, the Food and Drug Administration has issued a final rule to establish a unique device identifier for medical devices.
Compliance dates for various provisions in the rule, available here and effective 90 days after formal publication on Sept. 24, stretch out between 2014 and 2020. Congress authorized the UDI in 2007 to better enable users to track medical devices and enable the FDA to identify safety or effectiveness concerns quicker, and to better target recalls.
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