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

Tiomkin Law Offices of Elliott Tiomkin > Legal News  > FDA Streamlines 510(k) Process, As Courts Reconsider It

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

Law360 (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…

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