美国FDA移动医疗应用监管探究

摘要

目的 研究FDA对移动医疗应用的监管思路,为我国相关监管工作的开展提供经验借鉴.方法 对美国移动医疗应用指南和相关文献进行分析.结果 该文总结了FDA对移动医疗应用的监管政策、现存问题和政策新发展,提出我国应制定法律法规,完善相关监管,在政策制定过程中坚持保护公众健康与促进产业创新并重,建立合适高效的审批体系.%Objective To learn the U.S. FDA's regulations for mobile medical applications and promote the regulation work in our country. Method: Analyze guideline and relevant papers of the U.S. FDA mobile medical applications. Result This paper mainly summarizes the FDA's regulatory policies, existing problems and new development for mobile medical applications. China should formulate relevant laws and regulations, insist on protecting public health and promoting industrial innovation in policy making process, and establish appropriate and efficient approval system.