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Expert Analysis

FDA Streamlines 510(k) Process, As Courts Reconsider It

By Caitlin McHugh and Matthew Smith ( November 15, 2018, 12:39 PM EST) -- Change is in store for the Section 510(k) substantial equivalence approval process for Class II medical devices, both from the U.S. Food and Drug Administration and the courts. The FDA is working to streamline and expedite the Section 510(k) process, just as courts are giving more credence to the argument that Section 510(k) review and approval results in a finding of safety and effectiveness by the FDA — a trend which could have significant implications for punitive damages claims brought against manufacturers of Class II devices....

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