Regulating AI-Driven Software as a Medical Device (SaMD) and Generative AI in Regulatory Submission Automation: A Critical Analysis of FDA, EMA, and CDSCO Frameworks

Objective: This review paper provides an extensive comparative analysis of how the United States Food and Drug Administration (US FDA), European Medicines Agency (EMA), and India's Central Drugs Standard Control Organisation (CDSCO) govern AI-driven Software as a Medical Device (SaMD) algorithms. It focuses specifically on the operational deployment of Generative AI (GenAI) in automated regulatory document compilation, tracking the shift from standard electronic submissions to automated lifecycles.