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FDA Week - 11/30/2018

Device Industry Upset By FDA’s Plans To Drop Predicates From 510(k)

November 26, 2018
Device industry leaders were taken aback that FDA is considering publishing online the names of devices cleared using predicate devices that are 10 years old or older -- a move the agency announced Monday (Nov. 26) as part of a broader effort to modernize and tighten its medical device clearance process amid recent reports of safety issues. Aaron Josephson, senior director at ML Strategies, a former senior policy advisor at FDA’s device center and a former budget analyst at the...


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