April 24, 2024
FDA Digital Health Center of Excellence Overview
Digital Health Track
FDA Digital Health Center of Excellence has had a busy year. The DH CoE finalized guidances related to cybersecurity and the Voluntary Improvement Program, drafted its 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.
Kim Shoemaker, Senior Director, Global Regulatory Affairs, Ethicon
Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA