I have had type 1 diabetes for more than 30 years, which I manage using a glucose monitor connected to an insulin pump. One day, my physician encouraged me to explore new, open-source software that better manages the sensor and pump system. The agency generally regulates medical software as a device, which helps ensure it works as intended and is free from dangerous bugs. For example, it has exempted certain lower-risk applications and developed programs to expand the scope of software updates that do not require new regulatory review. The agreements submitted to Congress for debate next January could contain statutory reforms that would enable more effective review of medical software — including open-source software.