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

Abstract

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 Di