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Final UDI Rule Date Uncertain, But Firms Should Prep Now, FDA Says

This article was originally published in The Gray Sheet

Executive Summary

FDA likely won’t meet a May 2013 statutory deadline to issue final regulations for unique device identifiers, but that does not mean companies should delay efforts to comply. And firms should not rely on expected exemptions to the UDI mandate, an agency official said.

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The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.”

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