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US FDA's Gottlieb Takes Digital Device Questions From Senators At Cures Hearing

 
• By David Filmore

The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.

US FDA Commissioner Scott Gottlieb emphasized to Senators Dec. 7 the agency's goal to "go beyond" health-software provisions in the 21st Century Cures Act to allow FDA to exclude from regulation most digital devices and clinical decision software. Gottlieb testified before the Senate Health, Education, Labor and Pensions (HELP) Committee on the same day the agency issued three guidance documents that build on its initiative to streamline digital-health oversight.

Portions of the Medical Electronic Data Technology Enhancement for Consumer's Health Act (MEDTECH Act), originally sponsored by Sens. Michael Bennet,...

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