It has been more than two-and-a-half years since the U.S. Food and Drug Administration (FDA) issued its final rule on the Unique Device Identification (UDI) system. So, come September 24, the third deadline will be reached, requiring the balance of Class II medical devices to be compliant with the UDI rule which includes submitting them to the FDA’s Global Unique Device Identification Database (GUDID).
With the first two phases already implemented, Vice President, Healthcare, at GS1 US, Greg Bylo, helps us understand the previous deadlines and what medical device manufacturers need to do to prepare for the third phase.