2013年9月25日，FDA頒布了移動醫(yī)療應用的正式導則，針對日益廣泛應用在醫(yī)療器械和移動互聯(lián)網(wǎng)和終端設備上的軟體(Mobile Apps)，硬件等提出了建設性意見和指南。并將監(jiān)管重點放在用于維持人體生命等高風險的器械上；FDA將不斷改進和增加新的監(jiān)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.

詳細信息請訪問FDA在線：

FDA 移動醫(yī)療應用正式導則頒布：

Mobile Medical Applications

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

FDA移動醫(yī)療應用相關法規(guī)和指南：

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

GHTF格慧泰福國際認證服務部編譯整理

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