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QUOTED. Jan. 10, 2019. Scott Gottlieb.

Executive Summary

FDA will soon begin real-world testing of its "pre-cert" program for health software to find out if the program can be carried out within the agency's current regulatory authorities. FDA commissioner Scott Gottlieb believes it can be.

"We believe the most efficient way to test this type of program is to do so within the FDA’s current regulatory authorities. We know many stakeholders have had questions about how this would work." - Scott Gottlieb, commissioner, US FDA

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