Advancements in Clinical Evaluation and Regulatory Frameworks for AI-Driven Software as a Medical Device (SaMD)

Abstract

Owing to the rapid progress in artificial intelligence (AI) and the widespread use of generative learning, the problem of sparse data has been solved effectively in various research fields. The application of AI technologies has resulted in important transformations in healthcare, particularly in radiology. To ensure the high quality, safety, and effectiveness of AI and machine learning (ML) medical devices, the US Food and Drug Administration (FDA) has established regulatory guidelines to support the performance evaluation of medical devices. Furthermore, the FDA has proposed continuous surveillance requirements for AI/ML medical devices. This paper presents a summary of SaMD products that have passed the FDA 510 (k) AI/ML pathway, the challenges associated with the current AI/ML software-as-a-medical-device, and solutions for promoting the development of AI technologies in medicine. We hope to provide valuable information pertaining to medical-device design, development, and monitoring to ultimately achieve safer and more effective personalized medical services.

Keywords

• Software as a medical device (SaMD)
• AI/ML
• computer-aided detection (CADe)
• computer-aided diagnosis (CADx)
• computer-aided triage (CADt)