Anatomy Of A Unique Device Identifier: It’s Flexible
This article was originally published in The Silver Sheet
Executive Summary
Manufacturers will have leeway when creating product labels under FDA’s proposed UDI rule. Firms would be allowed to purchase an identifier from a UDI-issuing agency of its choice, although the agency strongly endorses the use of identifiers from GS1 and HIBCC. FDA’s Jay Crowley describes three different types of UDI labels.
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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.
Long Road To Unique Device Identification: FDA’s ‘Mr. UDI’ Offers Peek Behind Curtain
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.