FDA Week

FDA Launches Plan For Post-Market Regulation Of Digital Medical Devices

June 15, 2017
FDA Commissioner Scott Gottlieb announced Thursday (June 15) that the agency plans to pilot an entirely new approach for regulating digital health tools, such as mobile apps and fitness trackers. The agency is considering creating a third-party certification program so that lower-risk digital health products can be marketed without pre-market review, and higher risk products can be marketed with a streamlined pre-market review. An industry group representing clinical decision support software makers applauded the move, saying it seems industry and...

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