The FDA today released the final version of its guidance regarding the new unique device identifier program, a new mandate that requires certain medical devices to have coded labels that make them trackable via a national database.
U.S. regulators issued a finalized rule that encompasses prior guidances into a single document, providing the final rules on the global UDI database, advice for initial submissions and other elements of the program.
Aside from a few minor modifications, the final guidance maintains requirements set out in earlier documents, the FDA said. The agency in September 2013 released draft guidance on the UDI program, taking in more than 300 comments from 21 entities during the 60-day comment period that followed.
The UDI rules took into account some, but not all, of the industry’s direction, garnering both praise and concern from device makers. After issuing the initial guidance, the FDA relaxed some of the labeling requirements and pushed back some deadlines, but refused to budge on some formatting decisions.
The FDA plans to enact the UDI program in phases, focusing 1st on high-risk medical devices and exempting many of the low-risk ones from part or all of the requirements. In general, that means all Class III devices must carry UDIs on their labels and on their packaging within 1 year, and data on the devices must be submitted to the global database. Most Class II devices must comply within 2 years, and any Class I devices not exempt from the rule will have 5 years to comply. At 7 years the FDA will expect permanent markings on the devices themselves for all reusable Class I devices as well as all non-categorized devices that are still under the UDI rule.