Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review.

Abstract

This study explores the revolutionary potential of in-silico clinical trials (ISCTs) in medical device development, emphasizing the integration of computational modeling and simulation (CM&S), artificial intelligence (AI), and machine learning (ML). It evaluates regulatory advancements by the FDA, EMA, and PMDA, identifies barriers to global ISCTs adoption, and proposes strategies to enhance credibility, standardization, and ethical alignment. A systematic review following PRISMA 2020 guidelines