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US FDA examines results of pilots on UDI ahead of draft rule in 2011

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration undertook three pilot projects this year to explore the opportunities and challenges associated with the implementation of a unique device identification system for medical devices1. The agency is currently examining the results of these pilot activities as it prepares to issue – months later than originally planned – a draft rule next year on the mandatory use of UDI2.

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