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FDA’s Move To Publish Names Of Devices With Old Predicates As Part Of 510K Reform Shocks Industry

In an effort to modernize and tighten its medical device clearance process, the Food & Drug Administration (FDA) announced plans to publish the names of devices cleared using predicate devices that are 10 years and older. ML Strategies Senior Director Aaron Josephson, a former FDA Senior Policy Advisor, is among the industry sources quoted in the article providing commentary.


Inside Health Policy