FDA official expects delays on device-identification policy

06/15/2008 | FDAnews

Work on a proposed rule mandating a unique-device-identification system may not be completed until after the U.S. presidential election, said Jay Crowley, senior adviser for patient safety at the FDA's Center for Devices and Radiological Health. The rule for a UDI system, which would include a database with baseline data for each product, must be evaluated by the FDA and the Office of Management and Budget, Crowley said.

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