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Lingering Questions About UDI System

This article was originally published in The Silver Sheet

Executive Summary

Jay Crowley, CDRH's senior advisor for patient safety, answered questions about FDA's forthcoming industry-wide unique device identification (UDI) system during a May 19 interview with "The Silver Sheet." A new regulation will require the use of barcodes on products to track them after distribution. The agency plans to release a proposed rule for the UDI system by the end of this year, with a final rule due sometime in 2010.
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