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FDA: CDRH Plan of Action on 510(k), June 15, 2011

This FDA Plan of Action (here)  outlines 25 specific actions and accompanying timelines to make the 510(k) program “a blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to patients.”

You’ll recall, the Institute of Medicine in 2011 issued a report that concluded the 510(k) fast-track approval process which allows device manufacturers to bypass safety and efficacy requirements, is “fatally flawed” and should be abolished.

Thousands of medical devices are approved this way every year, including some that are permanently implanted.



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