GAO report says FDA approved some medical devices without close scientific review.

The New York Times (1/16, A15, Harris) reports, "Most medical devices have never been shown to be safe or effective, and for the riskiest devices this must change, Congressional investigators concluded in a report released Thursday." While the FDA "has promised for decades that it would fix the problem, it has not, leading the Government Accountability Office to state in the report that ‘it is imperative that the FDA take immediate steps’ to fix its system for approving devices."

USA Today (1/16, Rubin) reports, "Although the FDA has identified certain types of medical devices, such as artificial hips, as ‘presenting an unreasonably high risk to public health,’ the agency continues to approve some after little more scrutiny than it gives blood pressure cuffs."

CNN (1/16) reports on its web site that the GAO recommended "immediate steps" by the FDA "to ensure that high-risk medical devices, such as external cardiac compressors, get approved through the agency’s lengthy review process, not just cleared." The fact that the agency, from 2003 to 2007, "cleared 24 types of high-risk medical devices through a review process designed for lower risk devices" was the main subject of the concern from the Congressional watchdog. FDA spokeswoman Karen Riley addressed the report yesterday, saying, "In general we agree with the GAO’s conclusions" to "reclassify certain devices and require more stringent review for Class III devices." She added that the agency "is in the midst of looking at what options it has to change the system."

UPI (1/16) also covers the story, noting that the GAO "recommended the FDA fulfill promises it made 14 years ago to fix its system for approving complex medical devices." The AP (1/15) also covered the story.