UDI Rule Could See Light of Day Soon, OMB Sign-Off Expected, FDAer Says

The Office of Management and Budget (OMB) could release the FDA’s proposed rule on a unique device identification (UDI) system “any day now,” an agency official says, ending a nearly year-long delay in finalizing the much-anticipated safety mechanism. Pressure has been building on the OMB to move forward on UDIs. Sens. Herb Kohl (D-Wis.), Chuck Grassley (R-Iowa) and Richard Blumenthal (D-Conn.) wrote OMB Director Jeffrey Zients on Feb. 9 urging release of the rule, which has languished in the budget office since last July.
Devices & Diagnostics Letter