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merzkrashed replied to the topic Discussion Topic: Android app for measuring blood glucose in the forum Regulatory Basics for Medical Devices 8 years, 9 months ago
I found some examples of mobile medical applications the FDA has cleared or approved since 1997 from this link https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm368784.htm , also, FDA regulates mobile medical apps so Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. · FDA defines Mobile Medical Application (Mobile Medical App) to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.
FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. The FDA strongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality System regulation (which includes good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.