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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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FDA Blames Over-Reporting For Record-High Recall Count In 2013; Looks To Root Causes

The number of medical device recalls initiated by manufacturers last year hit an all-time high, according to an analysis by “The Silver Sheet.” FDA says the increase resulted in part from over-reporting of recalls by wary firms that were dinged in the past by the agency for not reporting. “Once a firm has been cited by an investigator, it is a wonderful reporter of recalls after that,” FDA official Ann Ferriter said in an interview. “They report a disproportionate number of recalls.” Meanwhile, the agency looks to root causes for answers. Failing to conduct thorough root cause investigations “sends a message to the FDA that maybe you do not have control over your recall,” CDRH Recall Branch Chief Ron Brown says.

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.

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