UDI Deadline Here Many Still Not Ready
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Karen Conway, Vice President, Healthcare Value
The deadline for Class II medical devices passed last month, and with Class III devices, all implantables regardless of class, and now Class II devices covered by the UDI regulation, more than 50 percent of devices sold in the United States should be labelled with unique device identifiers (UDI). However, a considerable number of manufacturers are still struggling to fully comply with the rule or create a sustainable process for ongoing compliance. Some may not have even begun the process. The final UDI ruling was published in September of 2013. With three years to prepare and several deadlines already passed, what is standing in the way of manufacturers? It turns out there is more than one reason many manufacturers haven’t completed their initial submissions to the FDA’s Global UDI Database (GUDID).
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