对美国FDA移动医疗应用指南文件的研究解读

摘要

本文对美国FDA发布的移动医疗应用程序指南文件进行研究解读，介绍了美国FDA对移动医疗应用程序的监管原则、方法和要求。%This article interprets the mobile medical application guidance which is published by U.S. Food and Drug Administration, and introduces the principles, methods and requirements in supervision of U.S. Food and Drug Administration about mobile medical applications.