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

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.

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, according to an agency official.

“If you’re a device manufacturer, I encourage you to start now, if you have not,” Jay Crowley, CDRH’s senior advisor...

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