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USFDA Digital Health Update – New actions and documents

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

Pre-Cert Working Model Version 1.0

Pre-Cert 2019 Test Plan

Pre-Cert Regulatory Framework for Conducting the Pilot Program

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