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  • djr32 started the topic Mobile Medical Applications in the forum Introduction to Project Management 8 years, 8 months ago

    When you open your Google play store or Apple Store, you can find an app for everything, even things related for medical purposes, such as an app that measures blood pressure.
    Moreover, the FDA has regulation for apps that are considered “mobile medical apps”. The FDA says that “mobile medical apps” is a mobile app that is intended “to be used as an accessory to a regulated medical device” or “to transform a mobile platform into a regulated medical device”.

    For my senior capstone project, my team and I developed an application that is used by people with hearing aids to retrain their auditory cues. Is this app considered a “mobile medical apps”? Why or why not? Give an example of a “mobile medical app” or if you have experience using a mobile medical app regulated by FDA?

    Reference:
    http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf