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Home » CDRH Aiming to Toughen Stance On Use of Old Predicate Devices
CDRH Aiming to Toughen Stance On Use of Old Predicate Devices
October 29, 2010
Amid calls from devicemakers to improve its policies on predicate devices and promises from CDRH to do so, the center is beginning to clarify changes that may be in the works as part of its 510(k) overhaul.