Read this well-written point of view regarding the FDA's medical device regulations and how they impact mobile applications . . . are they or aren't they medical devices?!
Drugwonks | A Regulatory App-ening:
" . . . during the session on mobile apps as medical devices. At present, there are some 17,828 healthcare and fitness apps and 14,558 that can be deemed “medical.” As Vice President Biden said, “It’s a big f**kin’ deal.”
But when is an app a medical device and when is it not? Not surprisingly, it depends."
'via Blog this'
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Essentials for Medical Device Manufacturer - Learn the basics of the FDA's QSR regulations
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