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FDA announces new guidelines for regulating medical software

By: geekwire.com 6 months ago

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.

News FDA announces new guidelines for regulating medical software

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How FDA announces new guidelines for regulating medical software

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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