Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management.
Others are targeted to health care providers as tools to improve and facilitate the delivery of patient care. These software devices include products that feature one or more software components, parts, or accessories, as well as devices that are composed solely of software.
Certain software functions / mobile apps that are device functions can pose potential risks to public health, and these are the subject of FDA concern and focused regulation. Mobile medical apps, as defined here, include only those mobile apps that:
Meet the definition of a device
Intended to be used as an accessory to a regulated medical device
Intended to transform a mobile platform into a regulated medical device. What are they as defined by the FDA, what are not? Requirements? Cybersecurity, documentation and validation requirements