Most recalled medical devices received speedy FDA review
Tuesday, February 15, 2011 - 00:31
in Health & Medicine
More than 70% of pulled devices were cleared for market under an abbreviated agency protocol, a five-year study has found. A study co-author calls the process inadequate.A disproportionate number of medical devices recalled because of possible links to serious health problems or deaths — including external defibrillators and insulin-infusion pumps — were approved under an abbreviated process that did not require advance testing on patients, according to a five-year study of such recalls.