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Does FDA Approval Process Slow Down Medical Device Innovation?


7/6/2011 8:39:33 AM

don’t want to become an FDA basher. It just seems like every year it is getting harder to push the medical device rock up the FDA hill. Speaking with peers, their perception has been similar, but last week the speculation was confirmed. I have never spent the time to actually look up FDA approval data. Last week, however, the Minnesota Congressional delegation published a letter to FDA commissioner Margaret Hamburg asking why Investigational Device Exemption (IDE) approval rates are so poor and quoted data. In 2000, according to the delegation, 76% of IDE’s were approved on their first review cycle. In 2010, that number had dropped to 32%. Less than half!



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