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Long Road To Unique Device Identification: FDA’s ‘Mr. UDI’ Offers Peek Behind Curtain

This article was originally published in The Silver Sheet

Executive Summary

The man who coined the term “Unique Device Identification,” Jay Crowley, opens up in an interview about hurdles FDA faced in setting up the system; anxiety he felt when Congress set a deadline for the final rule to be published; and why he believes UDI would have eventually happened organically anyway, among other UDI-related topics. “Sometimes people call me Mr. UDI … I think that name might stick for a while,” jokes Crowley, who planted seeds in 2002 for FDA’s new regulation to track and trace products. Since then it has mushroomed into an emerging program that has the backing of a majority in industry.

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UDI Milestone: Unique Identifiers Now Required For Class III Devices – But Are Some Firms Lagging Behind?

FDA’s requirement that high-risk devices bear distinctive identifiers has come and gone, 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 guru Jay Crowley.

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

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.”

News In Brief

FDA might consider how to make inspectional observations more meaningful to manufacturers; UDI point person Jay Crowley leaves FDA; and more.

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