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US Senators Lay Out Concerns On FDA Digital Health Device Precertification Program

 
• By Sue Darcey

Three senators led by Democrat Elizabeth Warren of Massachusetts on 30 October asked the Food and Drug Administration to answer a series of questions about its precertification pilot program for digital devices.

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Democratic Sens. Elizabeth Warren of Massachusetts, Patty Murray of Washington and Tina Smith of Minnesota want more details from the US Food and Drug Administration on the progress of its precertification program for digital health devices.

The senators are following up on a series of inquiries they sent to the FDA in 2018 regarding safety guardrails...

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