FDA Commissioner Outlines Next Steps for Pre-Cert Digital Health Pilot Program

摘要

The U.S. Food and Drug Administration (FDA) has drafted a regulatory framework to test new approaches for the review of digital health device applications. The purpose of FDA's Software Pre-Cert pilot is to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards, the agency said at the time.