The General Accounting Office (GAO) has criticized the Food & Drug Administration (FDA) for being too lenient in clearing critical, life sustaining devices. Meanwhile device manufacturers complain the U.S. is too slow compared to other countries.
The GAO told Congress this week that the approvals remain a serious issue even though it was raised more than two years ago. It should be noted that the device manufacturers major trade association, AdvaMed, has spent hundreds of thousands of dollars lobbying against any new device regulations.
Senate Aging Committee Chairman Herb Kohl, D-WI, said, "The drive toward getting new technologies to market shouldn't be done at the risk of patient safety."