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djr32 replied to the topic Device Class Confusion in the forum Project Management Process and Medical Device Development 8 years, 6 months ago
My capstone project was one that we were not sure if it would even go through FDA regulation. My capstone project is a mobile application that helps train users to discriminate auditory cue, such as discriminating pitch. We were also asked the question in my capstone class what class would our project fall under for the FDA. So, my team and I were not sure because our project was an app, but it is training someone’s hearing. Our app was equivalent to the FitBit, which is a device that monitors someone’s health. We conducted a Google search and we came across a whole new FDA classification called mobile medical applications. FDA said for a device to be considered a mobile medical application it has to be used in conjunction with an external medical device. For instance, if our app worked in conjunction with hearing aid. Then, it would be considered a mobile medical application. However, at the time the intended use of application was for people who had a hard time hearing or for people with normal hearing with a little hearing loss. Therefore, we learned that our app would not fall under any class or category.