The blood glucose meter is an existing product and as such is class 2. It is a medical device and falls under CDRH. The interesting component is that is transmits data to an android app. The thing in question here I feel is the sending device, not the receiving device. The part of the glucose meter that sends the data might be subject to safety concerns. However, devices that send/receive data are already on the market, such as implantable vagal nerve stimulators. So there is a good chance that this part of the device can be proven equal in function and thus the device as a whole is class 2. The fact that a doctor can recommend treatment changes because of this data I feel is out of the FDA’s jurisdiction. The doctor’s treatment recommendations are the doctor alone. He/she has the most knowledge and is ultimately responsible for their case.