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US FDA's New Game Plan For Digital Health

Commissioner Scott Gottlieb outlined his plans to implement software provisions of the 21st Century Cures Act and go much further than that in clarifying regulatory policy and piloting novel strategies to streamline the path to market for digital health technologies.

Digital Health

US FDA Commissioner Scott Gottlieb announced a coordinated strategy to remove regulatory ambiguity from the burgeoning field of digital health and keep agency device reviewers' hands off new software and mobile apps in as many cases as possible.

Gottlieb outlined his broad-strokes vision in a June 15 blog post, highlighting a plan to implement the software provisions in the 21st Century Cures Act and go beyond them to deregulate where possible, and map out a pilot oversight program that would

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