FDA Issues UDI Guide; Says Class II Device Makers Can Meet Labeling Deadline

FDA maintained that it gave manufacturers adequate time to label class II medical devices with a Unique Device Identifier, after issuing a draft guidance dated Tuesday (July 26) clarifying the required form and content of the UDI. Class II medical device packages and labels must bear a UDI by Sept. 24 under the 2013 rule. While multiple industry sources said the guidance was in line with existing FDA rules and guidances, one industry source speculated that FDA may have issued...