The IOM Report on Reform of the 510(k) Device Clearance Process and Beyond


In the second step of the Food and Drug Administration’s (FDA) initiative to assess and reform the 510(k) clearance process for Class II medical devices, the Institute of Medicine released its commissioned report on July 29, 2011, recommending that the FDA replace the 510(k) clearance process with a new regulatory framework. The IOM report should be noted by stakeholders for the significance of this recommendation and the extent to which it may impact the direction and scope of upcoming FDA changes to the medical device clearance process.

On July 29, 2011, the Institute of Medicine (IOM) released its highly anticipated report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” The report includes the organization’s controversial recommendation that the U.S. Food and Drug Administration (FDA) abandon the current 510(k) process and establish in its place a new regulatory framework for “moderate risk” Class II devices that “provides a reasonable assurance of safety and effectiveness.” Although the recommendation is not expected to be adopted, stakeholders should carefully consider the extent to which the report may influence the FDA’s and Congress’ respective regulatory and legislative agendas, as well as the FDA’s implementation of potentially significant changes to the 510(k) pre-market clearance process. The FDA will hold a public meeting on the IOM report on September 16, 2011. Comments on the report are due September 30, 2011.

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