MX: Marketing a fresh process

作者：Rothenberg S R^*; Sackman J E

来源：Medical Device and Diagnostic Industry, 2011, 33(12).

The IOM has released its independent review in July 2011. The taskforce concluded that the 510(k) process is not a reliable premarket screen of safety and effectiveness, and it recommended that FDA would be better served by eliminating the process altogether rather than expending any additional resources attempting to improve it. It recommended replacing the current system with an integrated premarket and postmarket regulatory framework to ensure the safety and effectiveness of future devices. Much of the recent scrutiny of the 510(k) process has focused on concerns about the safety of Class III devices that have been cleared through the process. The IOM made its recommendation that FDA would be better served by eliminating the 510(k) process than by attempting to improve it. While it is impossible to eliminate risks associated with medical devices, it is clear that FDA will require more effort, both premarket and postmarket, from device makers to improve safety.