FDA Considers Doctor-Like Competency-Based Tests for Medical Generative AI

FDA officials are exploring a competency-based evaluation framework for generative AI tools marketed as medical devices, modeled on how human clinicians are tested and credentialed. The proposed approach would assess clinical knowledge, analytic capabilities, safety behavior, communication, and generalizability of AI systems, with test rigor scaled to product risk profiles, potentially reshaping clinical AI governance and premarket approval standards.