FDA Delays UDI Date For Some Devices As It Finishes Convenience Kit Guide

September 8, 2016 at 3:18 PM
FDA has pushed back by two years the compliance date for UDI labeling of certain class II devices, citing a need to finalize a January guidance on convenience kits. One industry group had urged FDA back in April to delay this month's compliance date in light of the pending guidance. The agency announced the move Tuesday (Sept. 6) in a letter to device labelers as the original Sept. 24 compliance date approached. Thomas Gross, director of the Office of Surveillance...

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