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BioWorld - Sunday, December 8, 2019
Home » FDA grappling with Cures impact on software regs as Cures 2.0 unveiled
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FDA grappling with Cures impact on software regs as Cures 2.0 unveiled

November 26, 2019
By Mark McCarty
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The U.S. FDA has engaged in an overhaul of its software policies in the wake of the mandates spelled out by the 21st Century Cures Act. However, those policies are still a work in progress, as a recent FDA webinar made clear. The FDA won’t have long to put those policies into place as the U.S. House of Representatives is considering a follow-on to the Cures Act, dubbed Cures 2.0, which will impose yet more changes on the agency’s approach to software regulation.
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