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Feb 21, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

Cleveland Clinic, National Research Center for Women & Families regulatory update

Researchers at the center and clinic concluded that there are "critical flaws" in FDA's current medical device review system after an analysis of the agency's high-risk medical device recalls from 2005-2009 showed that 80 of 113 recalled devices were cleared through the agency's 510(k) process....

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