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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Pre-Cert Working Model Version 1.0
Pre-Cert 2019 Test Plan
Pre-Cert Regulatory Framework for Conducting the Pilot Program
Continue reading...