The article I looked at stated that the IOM report on the 510(k) process contains broad recommendations that may have significant consequences and impacts on the medical device industry. Specifically, IOM concluded that the 510(k) process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device” and that “the 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.”
Moreover, the report asserts that, FDA’s finite resources would be better invested in developing a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use, the committee said. The report also maintains that FDA should ensure that the new process allows devices to reach the market in as rapid and least burdensome a fashion as possible.
What this report does is require that all class II devices that are substantially equivalent will now have to go through extensive studies and additional approval process. It is not clear that there is evidence to make these recommendations. Throwing out the 510K process in favor of a more rigorous review process in the absence of evidence that there is an unacceptable risk posed by current class II devices has the potential to cause considerably more harm than good. It was clear given this restraint that additional regulations especially in the pre-market arena will result in vastly fewer devices coming to market. This result will help neither inventors nor patients.

Institute of Medicine Report Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years

In another article I read that “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programmes,”
Some of the Institute of Medicine’s recommendations, such as the recommendation to design a new regulatory framework for Class II (moderate risk) devices, may require congressional actions. However, the FDA plans to continue its review of the report and to solicit input from stakeholders regarding the recommendations in the report involving existing FDA authorities.

FDA to seek public opinion on Institute of Medicine’s 510(K) recommendations