The Food and Drug Administration is reviewing its practice of allowing third-party testing of new medical devices by companies hired by device makers.
The review follows reports of more than 300 cases of radiation overdose from CT scanners at four hospitals. According to FDA data reviewed by the Wall Street Journal, in the year ending Sept. 30, 2008, more than 300 devices went through the third-party review system, up from 185 new devices five years earlier. Of the radiological devices assessed by outside companies in the last decade, 80 percent were approved by the FDA without extra testing. The program was originally intended to provide tax savings but has come under fire within the FDA, with multiple scientists questioning whether enough information is available to the companies to make reliable assessments.
