Archive for June 2011

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

Jun 30th, 2011 | By

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
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