80 Percent of Recalled Medical Devices Got Little FDA Scrutiny

Of 113 medical devices recalled by the FDA between 2005 and 2009 because they were dangerous, 81% had been cleared under a lenient approval process revealing "critical flaws" in the federal review system, researchers say.

1 comments on "80 Percent of Recalled Medical Devices Got Little FDA Scrutiny"
Incredulous Reader (2/16/2011 at 5:26 PM)

How could this analysis have been published? So the news here is that most recalled devices were from the 510k process? since almost all devices use the 510K process how is this news? Also how many of these causes could have been detected by a clinical trial - you would not find manufacturing issues, for example. This is a very poorly done analysis.


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