Have a look at the FDA Guidance for pre-market solutions, they categorise device into 3 levels, major, moderate and minor. The minor level is for software that

Have a look at the FDA Guidance for pre-market solutions, they categorise device into 3 levels, major, moderate and minor. The minor level is for software that is unlikely that serious injury or death will result from the software: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#6 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...