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

ABSTRACT

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.

KEYWORDS:

• Artificial intelligence (AI)
• software as a medical device (SaMD)
• digital therapeutics (DTx)
• breakthrough devices program
• innovative medical device program
• international medical device regulators forum (IMDRF)
• regulatory science

Article highlights

• Applications of AI is being actively applied and utilized in the medical device field.

• With unmet medical needs and the development of advanced medical devices for clinical improvement are accelerating, and the US and Korea are conducting public-private partnerships for innovative technological interventions and outcomes.

• Analysis through the program confirmed that the combined proportion of artificial intelligence among designated software accounts for 58% (DTX, 8%) in the FDA and 100% in MFDS.

• Designated SaMDs are being increasingly utilized and authorized in cancer diagnosis, breast and thyroid scanning, fundus disease, Parkinson’s disease, chronic disease, cardiac arrest, and cerebral hemorrhage.

• International agreements or guidelines from regulators on performance, quality, clinical trials, and other topics are being developed to help SaMD and DTx find the best path to commercialization.

• Rapid technological innovations in SaMD will have a significant impact on the demand for licenses, suggesting the need for ongoing regulatory oversight to ensure optimal and productive collaboration between regulatory authorities and developers based on their initial experience.

• This study addresses need assessment and accelerated research approval. It also predicts innovative technologies and clinical solutions for patient groups and stakeholders in the clinical field. Findings of this study have technical, social, and policy implications.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This research was supported by the training program for advanced medical device industry professional manpower of Korea Health Industry Development Institute(KHIDI) funded by the Ministry of Health and Welfare, Republic of Korea.