Most Recalled Medical Devices Were Fast-Tracked By The FDA – Toledo, Ohio personal injury attorney

The Fast track the FDA uses for new drug approvals has been badly abused. The vast majority of the recalls over a five-year period were either fast tracked by the FDA or exempt from FDA approval. A study done in the Archives of Internal Medicine reports that113 devices were recalled between 2005 and 2009 due to serious health risks or death. 80 of those 113 were cleared through the 510(k) approval process, which is the fast track process, which is reserved for the lower risk products. The report also says that 8 of those 113 were exempt from FDA approval. Only 21 of those 113 were approved through the full premarket process.

  The FDA's 510(k) process has come under increased fire after journal reports were published; because of this the FDA said earlier this year they would be reforming the 501(k) process.  35% of the recalled devices were cardiovascular and the fast track process cleared two-thirds of those.
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