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We're sure that new heart valve is in perfect condition …
Washington Monthly, May, 2005 by Charles Peters
> There have been many reports about the FDA2's failure to monitor the performance of drugs after they've been approved. Now comes news that they failed to adequately monitor the performance of medical devices like heart valves that the agency has approved. Barry Meier of The New York Times has highlighted a FDA report that says, in Meier's words, "that the agency had little idea whether device manufacturers were fulfilling their obligations to conduct studies on the safety of products once they were on the market."
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