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Everything you Need to Know about SaMD from an FDA Perspective

Global Medical Device Podcast powered by Greenlight Guru

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Mobile Medical Applications

FDA has a guidance on this. It's, it's their policy for device software functions and mobile medical applications. And I'd say there are three key areas of FDA's oversight when it comes to let's call a mobile medical apps or it could be in another in another application, another form just as as some software function. These types of functions are similar to or perform the same functions as software devices that have been previously cleared or approved.

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