Senators question basis for FDA’s digital health pre-cert pilot image

Medical Design and Outsourcing, October 12, 2018
Chris Newmarker, featuring work by I. Glenn Cohen (Faculty Director)

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In another post on Aug. 16, 2017, on Health Affairs, Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen described the pre-cert program as “an experiment in medical product regulation” that lacks any statutory backing, even with passage of the 21st Century Cures Act, which FDA commissioner Scott Gottlieb has cited as an authorizing text. They seemed to be asking how the FDA will execute the plan without the legislative support of the 21st Century Cures Act, which doesn’t specifically call for the precertification program? (The authors note the plan “will likely be implemented through nonbinding guidance.”)

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