Blood glucose monitor can be considered a combination product as the sensor/ test strips that detect the blood glucose and the software that computes the calculation of these glucose levels are two different aspects of the device. The test strips are as important as the stability of the software running the device and both need to be regulated separately. In a recent article, the FDA after being reported by users of glucose monitors about the false low-level detection of glucose, points out that care should be taken by pharmacists and caregivers to use test strips that are specific to the particular meter that is being to used measure the glucose levels.

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/ucm162016.htm

In a very latest update last week Sep 27 2017, the FDA released an article that outlines the risk of absence of real-time alerts or alarms in situations like when the patient is sleeping. The FDA maintains that the information provided by software/mobile controlled non-invasive glucose meters in such cases maybe inaccurate and may still lead to non-alerted incidents of hypoglycemia and hyperglycemia.