News In Brief
This article was originally published in The Silver Sheet
Executive Summary
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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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.
FDA’s ISO Audit Program Chugs Along; May Be Absorbed By IMDRF Single-Audit Initiative
Thirty manufacturers have used FDA’s ISO 13485 voluntary audit program since the two-year pilot began last June, freeing up scarce agency inspectional resources to be used elsewhere. However, it will likely be eventually absorbed by a pilot Medical Device Single Audit Program currently under development by the International Medical Device Regulators Forum.
Anatomy Of A Unique Device Identifier: It’s Flexible
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.