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Home » Harkin Hints 510(k) Doomsday Plan Might Be Revived Via User Fee Bill
Harkin Hints 510(k) Doomsday Plan Might Be Revived Via User Fee Bill
November 18, 2011
Weeks after missing a self-imposed deadline to respond to Institute of Medicine (IOM) recommendations on the 510(k) process, CDRH Director Jeffrey Shuren told senators at a Tuesday hearing he’s unsure when the agency’s response will see daylight.