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510(k) Doomsday Plan May Be Revived Via User Fee Bill
December 8, 2011
Weeks after missing a self-imposed deadline to respond to Institute of Medicine (IOM) recommendations on the 510(k) process, U.S. Food and Drug Administration (FDA) official Jeffrey Shuren told senators at a Nov. 15 hearing he’s unsure when the agency’s response will see daylight.
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