IoM: FDA's 510(k) broken; should be replaced | theheart.org

After the Vioxx debacle the Institute of Medicine reported in The future of Drug Safety that the FDA was a demoralized, scientifically inadequate, underfunded agency statutorily obligated to grant quick drug approvals. It had almost no ability to effectively monitor the actual performance of drugs once they were in actual use. The entire "life cycle" of the drug needed to be regulated, the IOM concluded. Congress enacted modest reforms. Prompted by many device failures similar conclusions have been reached for the FDA's 510(k) process which is a quick once-over for new medical devices.

IoM: FDA's 510(k) broken; should be replaced | theheart.org:

"Washington, DC (updated) - The FDA's 510(k) process for clearing putatively moderate-risk devices has been criticized by some for being too lax and by others for obstructing innovation. Now, a long-awaited report from the Institute of Medicine (IoM) of the National Academies of Science concludes that the 510(k) process can't merely be repaired but ought to be scrapped and replaced by a more reliable system [1].

The FDA needs to replace the current regulatory framework for class II devices 'so that the current 510(k) process, in which the standard for clearance is substantial equivalence to previously cleared devices, can be replaced with an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle,' the IoM committee recommends in its report, released today at the National Academies of Science headquarters in Washington, DC."