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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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