501(K) PROCESS CALLED FLAWED /
An IOM committee recommends the FDA scrap it and invest in a process that assures safety.
An Institute of Medicine committee recommended that the Food and Drug Administration scrap its 510(k) process, a fast-track avenue available to medical devices that are “substantially equivalent” to another device already on the market, or to one cleared before 1976. The report concluded the process is too flawed to fix and the “FDA’s finite resources would be better invested in developing an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” The report concluded that a 510(k) clearance does not show that a comparable device is safe or effective because the majority of devices used as the basis for comparison were not reviewed for safety or effectiveness. The FDA, as well as the Advanced Medical Technology Association, which represents devicemakers, and the Medical Imaging and Technology Alliance said in separate statements that they do not support the IOM’s recommendation. The 510(k) process has been an ongoing issue in Washington, with policymakers and patient groups raising concerns about safety, while industry argues that the FDA’s approval process has become increasingly unpredictable.
GETTY IMAGES Devices can be fast-tracked if they are “substantially equivalent” to another device on the market.