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 System Faces Major Test As Manufacturers Work To Meet FDA’s Class III Device Deadline
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News In Brief
FDA might consider how to make inspectional observations more meaningful to manufacturers; UDI point person Jay Crowley leaves FDA; and more.