• FDA Begins Medical Device Safety and Innovation Overhaul

    3 monthes ago - By Surgical Aesthetics Magazine

    U.S. Food & Drug Administration commissioner, Scott Gottlieb, MD, released a statement on April 17, 2018, outlining the agency's efforts to “enhance and modernize” its approach to medical device safety and innovation. These efforts include a new medical device safety plan that will:
    1. Establish a robust medical device patient safety net in the U.S.
    2. Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations 3. Spur innovation towards safer medical devices 4. Advance medical device cybersecurity 5. Integrate the Center for Devices and...
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