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According to the FDA, what are medical mobile apps (MMAS)? Real-time data collection devices that are or are not wireless Commercial off-the-shelf computing platforms, with
According to the FDA, what are medical mobile apps (MMAS)? Real-time data collection devices that are or are not wireless Commercial off-the-shelf computing platforms, with or without wireless connectivity, which are handheld in nature Nonsignificant risk devices that qualify for exemption from FDA oversight Medical devices that are mobile apps, meet the definition of a medical device, and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device
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