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House Panel Approves Boosts For FDA Digital Health Plan, Quality Medtech Manufacturing

 
• By Sue Darcey

The US House Appropriations Committee in 2019 wants to give FDA an additional $40m to boost its digital health oversight, $12m more to “create a competitive marketplace for device quality,” and instructs the agency to keep working with Congress on a new laboratory-developed test regulatory path.

Capitol House

A key House panel has approved a US FDA spending bill for 2019 including $40m to expand a new digital health regulatory paradigm and $12m to support medtech quality manufacturing.

Additional riders in the appropriations bill – which now goes to the full House for consideration – call on FDA to report back to Congress in four months on medtech cybersecurity challenges and how best to deal with them, and urges FDA to continue

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