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FDA Examines Unique Identifiers; Industry Pushes Voluntary System

This article was originally published in The Gray Sheet

Executive Summary

FDA asks for comments on the potential for unique device identifier coding and offers details of its vision for such a system in a document published in the Aug. 11 Federal Register

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Unique Device Identification In 2008? FDA Decision Expected Soon

FDA will decide soon whether to mandate unique device identification through rulemaking. Should the agency determine that compulsory device identifiers are warranted, a proposed rule could be introduced as early as 2007, according to FDA Office of Science & Engineering Laboratories Director Larry Kessler

Unique Device Identification In 2008? FDA Decision Expected Soon

FDA will decide soon whether to mandate unique device identification through rulemaking. Should the agency determine that compulsory device identifiers are warranted, a proposed rule could be introduced as early as 2007, according to FDA Office of Science & Engineering Laboratories Director Larry Kessler

UDI meeting scheduled

FDA will convene a public meeting to discuss the use of unique device identification (UDI) systems on Oct. 25 in Gaithersburg, Md. (1"The Gray Sheet" Aug. 14, 2006, p. 7)...

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