The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software.

Introduction: Artificial Intelligence (AI) is becoming increasingly utilized in the medical device industry as it can address unmet demands in clinical sites and provide more patient treatment options. This study aims to analyze the FDA's Breakthrough Device Program and MFDS' Innovative Medical Device Program, which support regulatory science for innovative medical devices today. Through this study, it is intended to enable prediction of current development trends of Software as a Medical Device (SaMD) and Digital Therapeutics (DTx), which combine AI and technologies to be used in the clinical field soon.

Areas Covered: A systematic search was conducted on the broad topics of 'FDA and MFDS Program's SaMD, DTx.' A parallel review and update of PubMed, and the official websites were conducted to investigate the regulator's databases, review official press releases of regulatory agencies, and provide detailed descriptions of researchers.

Expert Opinion: The efforts of related stakeholders are needed to expand AI technology to diagnosis, prevention, and treatment technologies for diseases that are difficult to diagnose early or are classified as clinical challenges. It is important to prepare regulatory policies suitable for the rapid pace of technological development and to create an environment where regulatory science can be realized by developers.