IOM to FDA: Replace 510(k) Clearance Process
The U.S. Food and Drug Administration (FDA) should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, the Institute of Medicine (IOM) advises in a long-awaited report commissioned by the agency and released today. According to the report, the 510(k) process neither lacks the legal basis to serve as a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices, nor can it be transformed into one. FDA's finite resources, state the members of an IOM committee who were charged with writing the report, would be better invested in developing a new framework that employs both pre-market clearance and improved post-market surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use. The agency should also ensure that the new process allows devices to reach the market in as rapid and least burdensome a fashion as possible. Unlike the pre-market approval process, which requires manufacturers to submit results of safety and efficacy tests, the 510(k) clearance generally relies on "substantial equivalence" -- determining if new devices are sufficiently similar to comparable products that have been previously cleared or were on the market prior to 1975 when the 510(k) process was initially implemented via legislative action. However, the authors emphasize, reliance on substantial equivalence cannot assure that devices reaching the market are safe and effective, and 510(k) clearance does not determine a device to be safe or effective, the committee members write. "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," says Committee Chair David Challoner, vice president emeritus,health affairs at the University of Florida, Gainesville, Fla. "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.” FDA should explore whether a modified version of its de novo process—which reduces the amount of information manufacturers must supply for devices deemed to be of low or moderate risk but that have no predicate devices against which to be compared—could ould replace the 510(k) process, the committee members suggest. They also recommend that the agency identify and analyze those barriers that hamper the efficient and effective use of its regulatory tools and find ways to overcome them, and that Congress pass legislation to remove barriers to FDA's use of post-market regulatory authority. Just as significantly, the authors say, the FDA should develop and implement a comprehensive strategy to collect, analyze, and act on information about devices' performance after clearance, as well as promptly complete its task of determining how to handle 26 device types classified as "high risk" that are allowed to reach market through the 510(k) process. Devices considered substantially equivalent to products in these 26 categories continue to be cleared for the market through the 510(k) process. To read the report, click here: