News Headlines Article

Most recalled medical devices received speedy FDA review
Los Angeles Times

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.

More than 70% of the 113 recalled devices were cleared for market under a shorter Food and Drug Administration review because they were deemed similar to products already on the market, the study found.