FDA's 510(k) Device Approval Process Effective: Study

Law360, New York (September 16, 2010, 6:30 PM EDT) -- Of the nearly 47,000 medical devices cleared by the U.S. Food and Drug Administration's 510(k) review process since 1998, only 77, or 0.16 percent, were involved in a Class I recall between January 2005 and May 2010, a new study by a medical device industry group shows.

In contrast, of the 2,825 medical devices cleared since 1998 through the FDA's premarket approval process, 24 devices, or 0.85 percent, have been the subject of a Class I recall during this 64-month period, according to the study, released...
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