News Headlines Article

80% of Recalled Medical Devices Got Little FDA Scrutiny
Health Leaders Media

Of 113 medical devices recalled by the FDA between 2005 and 2009 because they were dangerous, 81% had been cleared under a lenient process reserved for devices deemed “substantially equivalent” to others already approved, revealing “critical flaws” in the federal review system.

That’s the conclusion of a report in Tuesday’s Archives of Internal Medicine that evaluated each medical device.