Report Blames Speedy FDA Clearance for Medical Device Recalls

Bloomberg Businessweek, February 16, 2011

Most medical devices recently recalled by the U.S. Food and Drug Administration for posing life-threatening or serious safety risks were initially approved for use by that same agency through an expedited approval process, new research reveals.

The findings call out for an overhaul of the regulatory process, to keep unsafe products from reaching the market in the first place, said the study team, led by Diana M. Zuckerman of the National Research Center for Women & Families, based in Washington D.C.

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