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FDA移动医疗应用正式导则颁布Mobile Medical Applications (Mobile Apps)

2013年9月25日，FDA颁布了移动医疗应用的正式导则，针对日益广泛应用在医疗器械和移动互联网和终端设备上的软体(Mobile Apps)，硬件等提出了建设性意见和指南。并将监管重点放在用于维持人体生命等高风险的器械上；FDA将不断改进和增加新的监管要求。

FDA will focus its oversight on medical mobile apps that meet the definition of device in the Federal Food, Drug, and Cosmetic Act and are intended to:

-          transform a mobile device into a medical device regulated by FDA; or

-          be used as an accessory to a medical device regulated by the FDA.

FDA intends to exercise enforcement discretion for other mobile apps. This focuses FDA's regulatory priorities on the small subset of mobile medical apps that could present a greater risk to health.

详细信息请访问FDA在线：

FDA 移动医疗应用正式导则颁布：

Mobile Medical Applications

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA移动医疗应用相关法规和指南：

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

IRC编译整理

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