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Healthcare groups await FDA's rule on unique device identification

This article was originally published in Clinica

Executive Summary

The US FDA has apparently not yet set a date for a rulemaking on a unique device identification (UDI) system. The system has been on the FDA’s drawing board for five years now and, most recently, a coalition of US healthcare groups told the FDA not to delay issuing a rulemaking any longer. Today, when asked for a date for the rulemaking, the FDA told Clinica that “there is specific timeline for this rule”.

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