Category: Digital Health
TGA presentation: Digital Devices Webinar 3, 20 June 2019
Digital Health Update: Mid-Year Update on Software Precertification Program
Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program
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
