High-Risk Recalls Have Weaker Approval Process: Study

Law360, New York (February 15, 2011, 3:47 PM EST) -- Most medical devices recalled by the U.S. Food and Drug Administration between 2005 and 2009 because they could cause serious health problems or death did not go through the agency's most stringent approval process, according to a new study.

The study published Monday in the Archives of Internal Medicine reviewed 113 “high-risk” recalls during that time frame.

Of those recalls, 80 involved devices that were cleared through the FDA's 510(k) process, according to the study, authored by Diana M. Zuckerman and Paul Brown of the National...
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