Pratik Shah Invited to the FDA Digital Health Advisory Committee on Generative AI
November 20-21, 2024
8:00am - 6:00PM ET
Gaithersburg, MD
Background
The U.S. Food and Drug Administration (FDA) established the Digital Health Advisory Committee to provide advice and recommendations on complex regulatory issues for emerging technologies. Dr. Shah was invited to participate as an expert member in the committee’s public meeting, which focused on one of the most pressing topics in modern medicine: The total product lifecycle considerations for Generative Artificial Intelligence (AI)-enabled medical devices. The committee’s discussion aimed to help shape FDA policy and provide recommendations on ensuring the safety, effectiveness, and regulatory oversight of these rapidly evolving technologies.
Target Audience and Value Proposition
This public meeting served as a forum for researchers, medical device developers, clinicians, and regulatory affairs professionals. As a committee participant, Dr. Shah contributed his expertise in generative AI, computational modeling, and the real-world performance evaluation of AI-enabled medical devices. His insights helped inform the committee’s recommendations to the FDA, particularly concerning the regulatory science needed to validate Generative AI tools for safe and equitable clinical use.