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The U.S. Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new report from the IOM.
Prompted by concerns that have been raised about whether the 510(k) clearance process is adequately protecting and promoting the public’s health, the FDA asked the IOM to convene a committee to evaluate the process and make recommendations aimed at protecting public health while preserving a mechanism to get new medical devices to market in a timely manner.