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- FDA Issues Long Awaited Draft Guidance Documents Concerning Internet Social Media
FDA Issues Long-Awaited Draft Guidance Documents Concerning Internet/Social Media
July 1, 2014, InsideMedicalDevices Blog
December 20, 2017, Covington Alert
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...