Each year, the U.S. Food and Drug Administration logs some 100,000 reports of adverse events related to medical devices. More than a third of those are due to human error.
The FDA should develop a new regulatory
framework to replace the 510(k) clearance process for moderate-risk medical
devices, advises a report issued July 29 by the Institute of Medicine.
The FDA's new Medical Device Innovation Initiative aims to facilitate the development and evaluation of new medical devices; strengthen the nation’s research infrastructure; and respond quickly to scientific breakthroughs.
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