Research Forum: What do you mean it’s a medical device? Understanding FDA regulations in the era of AI, ML, and medical mobile apps

Are you developing a new mobile app to assist patients in preparing for a clinic visit? Or working on an artificial intelligence program to help better understand imaging results? If you are then you may be developing Software as Medical Device (SaMD). Does that mean the software is FDA regulated? Are there things you should be considering in developing the technology? If you’re looking for help answering these questions and more, register for this informative research forum!