TY - JOUR
T1 - The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software
AU - Woo, Jae Hyun
AU - Kim, Eun Cheol
AU - Kim, Sung Min
N1 - Publisher Copyright:
© 2022 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Artificial intelligence (AI)
KW - breakthrough devices program
KW - digital therapeutics (DTx)
KW - innovative medical device program
KW - international medical device regulators forum (IMDRF)
KW - regulatory science
KW - software as a medical device (SaMD)
UR - http://www.scopus.com/inward/record.url?scp=85127214994&partnerID=8YFLogxK
U2 - 10.1080/17434440.2022.2051479
DO - 10.1080/17434440.2022.2051479
M3 - Review article
C2 - 35255755
AN - SCOPUS:85127214994
SN - 1743-4440
VL - 19
SP - 213
EP - 228
JO - Expert Review of Medical Devices
JF - Expert Review of Medical Devices
IS - 3
ER -