When Are Clinical Decision Support Tools FDA Regulated (considered Medical Devices)

I created this decision tree based off the FDA’s recent guidance on Clinical Decision Support Tools. The actual link to that guidance is here:

https://www.fda.gov/medical-devices/software-medical-device-samd/your-clinical-decision-support-software-it-medical-device

My hope was to make a simplified decision tree to aid IRB’s in determining when or if their clinical decision support tools are considered “medical devices” and therefore require adherence to the FDA regs.

And here is the actual FDA version (which I also absolutely LOVE!)

Let me know what you think!