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- FDA Issues Long Awaited Draft Guidance Documents Concerning Internet Social Media
FDA Issues Long-Awaited Draft Guidance Documents Concerning Internet/Social Media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 6, 2016, Covington Alert
On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, ...