FDA New Digital Health Policy Statement

On December 7, 2017, FDA Commissioner Scott Gottlieb, M.D., released the statement, “Advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation.” This statement announces the release of several new draft and final guidances as part of the FDA’s Health Innovation Action Plan published previously. The new guidances are posted separately and include SaMD Clinical Evaluation, Clinical and Patient Decision Support, and Changes to Existing Medical Policy resulting from Section 30260 of the 21st Century Cures Act.

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