Summary
Establishes a national implementation plan to integrate AI across drug, medical-device, and cosmetics regulation through improved data infrastructure, specialized models and agents, and AI-assisted review, inspection, surveillance, and regulatory services, with human-machine collaboration and security controls.
Healthcare Implications
Regulated-product developers should expect growing AI-assisted review and surveillance and stronger demands for structured, traceable, and high-quality data. Regulators are directed to validate tools, control access and security, review compliance, preserve accountable human decisions, and continuously evaluate performance.