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UDI System Faces Major Test As Manufacturers Work To Meet FDA’s Class III Device Deadline

This article was originally published in The Silver Sheet

Executive Summary

Manufacturers of high-risk medical devices are staring down the barrel of a Sept. 24 deadline to comply with FDA’s UDI system. Anita Rayner of CDRH’s Office of Surveillance and Biometrics says “industry is making a great effort not only to comply, but to provide us with constructive feedback,” yet some industry experts say there are firms still struggling to determine the type of product data they need to feed into the agency’s Global Unique Device Identification Database. “Collecting data attributes is the hardest part of implementing UDI, by far,” says UDI expert Jay Crowley. He also has another message for firms: Know which entity will serve as labeler of the device. Further, FDA strongly hints that it will use enforcement discretion to give firms and field investigators time to become accustomed to the new UDI requirements, although industry insider Steven Niedelman warns that investigators will use UDI “as a tool to drive right through your quality system.”


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