FDA Seeks Comments on Medical Device Market Recommendations
The Food and Drug Administration is requesting public comments on the Institute of Medicine’s report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” FDA is also planning a public meeting in the coming weeks…
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to discuss recommendations made in the report. (In order for a manufacturer to begin marketing a device subject to 510(k) review, FDA must “clear” a premarket notification (510(k)) demonstrating that the new or modified product is substantially equivalent to another legally marketed “predicate” device.)