FDAnews Device Daily Bulletin

FDA: UDI Likely Delayed Until After Election

June 16, 2008

Devicemakers will see more delays to a proposed rule on a unique device identification (UDI) system — probably until after the presidential election, an FDA official says.

The rule must go through the agency as well as the Office of Management and Budget, Jay Crowley, senior adviser for patient safety with CDRH, said.

Crowley noted that it is an election year, which “really slows things up.” The FDA is continuing to work on the proposed rule, but “we’ll probably have to wait for the new administration,” he said.

The identification system would be similar to the bar codes on drugs and biologics and would involve a database with baseline information for each device.