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Home » FDA Open to Second Pathway Alongside 510(k) For Class II
FDA Open to Second Pathway Alongside 510(k) For Class II
August 5, 2011
Days after balking at an Institute of Medicine (IOM) report suggesting that the FDA scrap its 510(k) device clearance process, the agency said it may develop a second regulatory pathway for Class II devices that would operate in parallel to 510(k).