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FDA Announces First Steps in Medical Device Approval Overhaul
19 days ago - By Surgical Aesthetics Magazine
On November 20, 2018, the U.S. Food and Drug Administration released a statement outlining the steps it is taking to overhaul its existing medical device approval process. The agency's first goal is to enhance post-market safety by investing in new tools and developing new policies to identify and act upon safety signals related to existing medical devices.
The current post-market surveillance program depends on users to report problems. The new strategy is to use the FDA's unique device identification system to generate, access and evaluate large data sets on device performance and...
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