“Rather than continuing to modify the 35-year-old 510(k) process… FDA’s finite resources would be better invested in developing an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle,” concludes advisory report from Institute of Medicine to FDA.
“FDA believes that the 510(k) process should not be eliminated,” says Jeffrey Shuren, M.D., J.D., honcho of FDA’s Center for Devices and Radiological Health (CDRH), “but,” he adds, “ we are open to additional proposals and approaches for continued improvement of our device review programs” .
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