The analysis, performed by the National Research Center for Women & Families and the Cleveland Clinic and published in the Archives of Internal Medicine, examined 113 devices recalled by the FDA between 2005 and 2009. The analysis found that 71 percent of the devices were approved under the 510(k) process. This process requires the device be similar to an already-approved device and is considered less stringent than other approval requirements.
Fifty-one percent of the recalled items were for general hospital use, anesthesiology, clinical chemistry, neurology and ophthalmology.
Read the Archives of Internal Medicine report on FDA recalls.
Read more on the FDA:
–Study: Recalled Medical Devices Were Cleared Through Less Stringent 510K Process
–FDA Draft Guidance: Recommended Warning for Surgeon’s and Patient Examination Gloves That Use Powder
–FDA Awards Contract to Develop Sentinel System Pilot for Evaluating Medical Product Safety
