FDA Digital Health Center of Excellence Overview

FDA Digital Health Center of Excellence has had a busy year. The DH CoE finalized guidances related to cybersecurity and drafted their Predetermined Change Control Plan (PCCP) guidance for AI/ML enabled medical device software functions, collaborated with international regulatory authorities to publish AI/ML-related PCCP principles, and contributed to proposed rules and policy statements from other U.S. agencies. The DH CoE continues to be the go-to area of the FDA for a wide variety of digital health needs from the policy level to the process.