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dipanpatel replied to the topic Discussion Topic: Android app for measuring blood glucose in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
To take a tangent off what you said, it is exciting to see Wireless medical devices, mobile medical apps
and health IT becoming more and more prominent. It’s also reassuring to see that the FDA is taking steps to have regulation set on that part of health technologies. With the advancing of wearables and their ability to track health, it can soon require FDA approval. For example, medical apps require going on “Federal Trade Commission’s website to find out when FDA, Federal Trade Commission (FTC) or Office of Civil Rights (OCR) laws apply.” It is also good to see that the Center for devices and radiological health has a digital health program to better protect public health. With these new technologies coming out to support efficient testing and monitoring, it is reassuring to see the FDA try to keep up with the exponential growth of technology.