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Digital Health, Cybersecurity Would See Significant Chunk Of FDA Device-Funding Boost

 
• By Sue Darcey

If Congress approves a 26% higher 2019 funding request for US FDA's device center, a substantial chunk of those dollars would go to building a novel framework for regulating digital-health technologies, and to help FDA and device manufacturers respond better to cybersecurity vulnerabilities, among other program priorities, according to agency officials.

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US FDA's Center for Devices and Radiological Health has big plans to use a proposed increase in funding – from $505m in 2018 to $636m in 2019 – to build a new digital health regulatory framework and enhance cybersecurity protection for devices. The funds would also go to support stepping up efforts to revamp how FDA assesses device manufacturing activities and how it leverages real-world data using the National Evaluation System for health Technology (NEST), according to FDA Commissioner Scott Gottlieb.

Earlier this week, the Trump administration proposed a $131m raise for the device center and a planned 17% increase for...

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