Case study: Neither a SaMD, nor a SiMD; maybe a SaMDA?
A mobile medical app crashing can cause a life-threatening emergency and send you to the hospital. It seems to have fallen through a crack in the regulatory framework for medical software.
Imagine you have Type I diabetes and you rely on your smart insulin pump to manage blood glucose levels in a tight range. It is so smart that you can even control it from a mobile app to deliver an on-demand bolus insulin (i.e. a short acting boost) when you are about to enjoy a special celebratory meal with family and friends!
The mobile app also displays all kind of useful data such as glucose trends, insulin delivery history, insulin on board, carbs, continuous glucose monitoring sensor status, and even important alerts and alarms1.
There is just a small problem.
If you have an older version of this mobile app running on the Apple iOS platform (i.e., iPhone, iPad etc.), the app could crash without warning and be automatically relaunched by the iOS operating system. This cycle may repeat several times, which in turn, can drain the pump battery, resulting in a pump shutdown and interruption in insulin delivery.
According to the Class I recall announcement from the FDA2:
Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin.
There have been 224 reported injuries as of April 15, 2024 and no reports of death.
Clearly, this is a serious issue that has already resulted in many reports of injury to patients.
How could this happen?
The specific functionality of this mobile app which controls the pump to deliver an on-demand bolus insulin certainly meets FDA’s definition of a device software function3 deployed on a mobile platform. However, the regulatory history of this mobile app indicates that it is not regulated as a standalone medical device, rather as an accessory to the insulin pump.
Note that it cannot be treated as a Software in a Medical Device (SiMD) because it is not a part of the insulin pump software, rather a standalone software operating on a mobile platform.
It also does not meet the definition of a Software as a Medical Device (SaMD) because this specific functionality controls another hardware medical device4, that is, the insulin pump.
So, if it is not a SaMD, neither a SiMD, what is it?
Perhaps we should treat it as a SaMDA, or Software as a Medical Device Accessory. But there is no formal definition of SaMDA which can inform an appropriate regulatory approach for these types of device software functions to ensure they are safe and effective.
There is a crack in the regulatory framework for medical software through which this mobile app seems to have fallen through!
In this article, we will explore this question in the context of the regulatory history of the t:connect mobile app, it’s relationship to the t:slim X2 insulin pump, and how it fits within the regulatory framework of a medical device accessory.
Lets us dive in.
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