Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years;” Request for Comments

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The Food and Drug Administration (FDA) is requesting comments on the Institute of Medicine (IOM) report entitled: "Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years." The establishment of this public docket does not signify FDA endorsement or concurrence with any of the conclusions or recommendations contained within the report. FDA may, in the future, take additional measures to solicit public input in the report and specific recommendations contained therein. FDA will not adopt any of the recommendations contained in the report before the close of this comment period.