Presents
April 24, 2024 @ 12:05 pm
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1:15 pm
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 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.
Moderator
Kim Shoemaker, Senior Director, Global Regulatory Affairs, Johnson & Johnson MedTech
Speakers
Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA
Diane Johnson, Senior Director North American Policy, Global Digital Health Policy Lead, Johnson & Johnson MedTech
