怎么找手机医用app申请510K的例子？ - RegulatoryAffairs版 - 未名存档

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RegulatoryAffairs版 - 怎么找手机医用app申请510K的例子？

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b*****5 发帖数: 98	1 有国内的同学需要做这个，在FDA的网站上找不到例子。托我问。我是在医疗器械版看到有这个新版过来请教的。多谢多谢！
l********e 发帖数: 755	2 同问
f*****u 发帖数: 15	3 偶然看到这个网页，应该是你找的东西： Examples of MMAs (Mobile Medical Applications) the FDA Has Cleared or Approved since 1997: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368784.htm 还有这个2013年FDA issued final guidance on mobile medical apps, 里面有申请的指导原则： http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
s**********8 发帖数: 25265	4 nice. FDA just released the revised version on Mobile Medical Application guidance for industry on Feb 9th, 2015, very fresh. another fda regading wireless hardware is draft guidance: radio frequency wireless technology in medical device 【在 f*****u 的大作中提到】 : 偶然看到这个网页，应该是你找的东西： : Examples of MMAs (Mobile Medical Applications) the FDA Has Cleared or : Approved since 1997: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368784.htm : 还有这个2013年FDA issued final guidance on mobile medical apps, 里面有申请的 : 指导原则： : http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
f*****u 发帖数: 15	5 Yes, I also saw the news and was looking at the FDA website for the new guidance. Just foudn it and here is the link of the new guidance on Mobile Medical Application released on Feb 9th, 2015: http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf

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