Question

according to the fda, what are medical mobile apps (mmas)?real-time data collection devices that are or are not wirelessmedical 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 devicecommercial off-the-shelf computing platforms, with or without wireless connectivity, which are handheld in naturenonsignificant risk devices that qualify for exemption from fda oversight

Answer 1

Medical mobile apps (MMAs) are software programs that meet the criteria for a medical device and are designed for use on a mobile platform, such as a smartphone or tablet.

The term "medical devices" refers to software programs that fit the definition of a medical device and are designed for usage on mobile platforms. Additionally, according to the FDA, MMAs fall under one of two categories: "serious risk devices" or "nonsignificant risk devices."

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