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  • sp2387 replied to the topic Update to Classification System in the forum Introduction to Project Management 6 years, 2 months ago

    Well ryan your way of thinking may be right but as we know FDA classification is more of risk based.Ibased.I believe that the device name looks like it must be class 3 device because it is attached to heart but risk of using the device is lower then any class 3 device that are more likely to fail when used. Maybe this is why it has been classified among the class 2 devices.