![]() ![]() ![]() Without clear evidence the committee is recommending that the 510K process of approving substantially equivalent devices be scrapped in favor of adding additional studies and potentially delaying approval of competitive devices. While current information is not adequate to immediately start designing a new framework, we believe the agency can get the necessary data and establish a new process within a reasonable time frame.”Īs we noted yesterday, there is legal concern mounting already about the composition of the IOM committee as it pertains to the Federal Advisory Committee Act and the lack of fair balance representation. “The 510(k) process cannot achieve its stated goals - to promote innovation and make safe, effective devices available to patients in a timely manner - because they are fundamentally at odds with the statutes that govern how FDA must implement the process. “It’s not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help,” said committee chair David Challoner, emeritus vice president for health affairs, University of Florida, Gainesville. 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. 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. 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.” The new framework would increase the public’s confidence that safe and effective medical devices are being made available in a timely manner.Īs described below, the IOM report on the 510(k) process contains broad recommendations that may have significant consequences and impacts on the medical device industry. The committee believes that taking the recommended steps will generate the information needed to design a robust regulatory framework for Class II devices. The report and recommendations are focused on strengthening the science base needed to make better-informed regulatory decisions and on giving FDA the tools that it needs to identify and remove problematic devices from the market. Some Class I and Class III device types also are cleared through the 510(k) process. More than 80% of 510(k)-cleared devices are categorized as Class II device types. ![]() ![]() The premarket notification, or the 510(k) clearance process, named after Section 510(k) of the authorizing legislation passed by Congress in 1976, is the primary pathway to market for Class II devices. Today, the Institute of Medicine (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process released its long awaited, 245-page report, entitled, “Medical Devices and the Public’s Health The FDA 510(k) Clearance Process at 35 Years.” ![]()
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