FDA announces new guidelines for regulating medical software -

FDA announces new guidelines for regulating medical software

Credit: geekwire.com

  • Dec 07 2017 22:50About: 5 days ago
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News Brief: The Food and Drug Administration released new guidance for developers making medical software Thursday, clarifying which kinds of software will be regulated as a medical device. The three new guidelines, two of which aren’t yet final, say that software like wellness apps and wearables that monitor health markers won’t be regulated as strictly as medical devices. The move will likely open the area for more innovation as developers have a clearer understanding of the standards their products must meet.



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News Brief: Food Drug Administration released guidance developers making medical software Thursday clarifying which kinds will regulated device. three guidelines aren’t final that like wellness apps wearables monitor health markers won’t strictly devices. move likely open area more innovation have clearer understanding standards their products must meet.

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