The report by the institute of medicine talks about how the 510k process has become burdensome and time-consuming and addressed the inadequacies of post market regulations of medical devices by the FDA. The report mainly focuses on under regulation of medical devices even though sporadic cases of adverse effects of the device have been reported. It also argues about how the 510k process uses age old policies and instead of modifying this lengthy process, it is necessary to create a new regulatory framework with reasonable objectives that does not compromise the safety or effectiveness of the devices throughout the lifecycle of the device or hamper the innovation or timely approval of new devices that show promising results.

http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Process%202011%20Report%20Brief.pdf