Medical devices, everything from tongue depressors to pace makers and defibrillators, are regulated by the FDA. How competently or effectively the FDA regulates these products has been questioned for several years in part due to the substantial increase in recent years in product recalls, for example the recall of certain hip implant devices. More specifically is the question whether the FDA's 510(k) process, that reviews or “clears for the market” medical devices, is adequate. An IOM study of the topic released in July 2011 reached the unanticipated and controversial conclusion that since, in part, 510(k) determines only “substantial equivalence” in clearing devices for the market, i.e., it does not evaluate device safety and effectiveness, the process should be scrapped and replaced. (Listeners will recall Dr.