The Food and Drug Administration has sent a final rule to establish a unique medical device identifier to the Office of Management and Budget for review before publication.
The long-awaited identifier, which Congress authorized in 2007, is designed to better enable users to track devices and enable FDA to identify safety or effectiveness concerns quicker and better target recalls.
A proposed rule issued in July 2012 defines a UDI as “a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current product information for that specific device, such as the lot or batch number, the serial number and/or expiration date,” Under the proposed rule, the FDA would create a database containing a standard set of basic identifying elements for each specific device model, and will make most of the information publicly available.
Multiple industry stakeholders criticized long implementation timetables in the proposed rule that stretched out up to seven years. Consequently, FDA in November 2012 amended the proposed rule. Some timetables were reduced, with implantable devices having to bear a unique device identifier as a permanent marking on the device either one, three or five years earlier than first proposed, depending on the device.
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