Conscience December 2024 Policy Brief - Regulatory Issues with AI-enabled medical devices

Regulatory Issues with AI-enabled medical devices Innovative AI-enabled medical devices have presented a regulatory challenge to the FDA, as the agency’s current approval and regulation process is not equipped to manage devices equipped with adaptive AI and machine learning capabilities. On December 4th, the FDA issued its final Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, completing a drafting process that began in April 2019. This Policy Brief explains the Recommendations and the lessons learned about their purpose and enforceability.