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UDI Expands, Questions Roll In, And Debate Over System Adoption Continues

As 2015 comes to a close, "The Gray Sheet" looks at the current state of the Unique Device Identification program, persistent challenges for companies and what to expect in the year ahead. UDI guru Jay Crowley provides insight.

While the Unique Device Identification requirements first took effect in 2014, the UDI mandate remains a dynamic issue for industry as more and more devices become subject to UDI labeling and database submissions each year.

Companies still have questions about proper compliance to the UDI rules, says Jay Crowley, a former FDA official credited with...

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