IOM Report Urges FDA Shift from 510(k) Program | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) –The Institute of Medicine today proposed that the US Food and Drug Administration effectively scrap its 35 year-old 510(k) medical devices clearance program in favor of a hybrid model that would mix pre-market and post-market review activities in order to better protect consumers and promote innovation.

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