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UDI proposed rule may soon be released

This article was originally published in The Silver Sheet

Executive Summary

A proposed rule on a unique device identification (UDI) program could be ready by summer, said Jay Crowley, CDRH's senior advisor for patient safety and head of FDA's UDI initiative. The projected final rule publication would come about a year later, he said. Crowley's comments came during a March 9 session of the AAMI/FDA International Conference on Medical Device Standards and Regulation in Reston, Va. The UDI program will require devices to bear a standardized barcode for tracking from manufacture to patient use ("The Silver Sheet" June 2009)
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