AI醫療器材之管制及規範問題—以美國FDA對軟體類醫療器材之管控為例【全球瞭望】 試閱
Regulatory and Compliance Issues of AI Medical Devices: An Analysis of the FDA's Regulation of Software as a Medical Device in the United States
隨著AI技術日新月異，AI醫療器材成為醫療產業一項重要發展領域，本文探討美國FDA於De Novo、上市前批准（PMA）和上市前通知510(k)等審核途徑下對軟體類醫療器材（SaMD）之監管框架；此外，本文亦探討AI醫療器材於發展過程中可能面臨之倫理及規範問題，如資料透明度、風險管理、隱私保護等，並介紹了國際間AI醫療器材主要規範機構及其合作，為未來立法者及產業人士提供參考。
As AI technology rapidly evolves, AI medical devices have become a significant area of development within the healthcare industry. This paper explores the regulatory framework for Software as a Medical Device (SaMD) under various U.S. FDA review pathways, including De Novo, Premarket Approval (PMA), and Premarket Notification 510(k). Additionally, the paper examines the ethical and regulatory challenges that AI medical devices may encounter during their development, such as data transparency, risk management, and privacy protection. It also introduces the key international regulatory bodies for AI medical devices and their collaborations, providing reference for future legislators and industry professionals.
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