I would agree with the above posts that an artificial organ would be a class III device. Class III devices are typically the ones that pose the greatest risk to a patient and as you can imagine an artificial heart, let’s say, can pose a huge risk to a person if it fails. I am sure the business will need a Premarket Approval which is the most strict device marketing application. It is required for devices that have no existing equivalents. Initially, the company would have to do an exhaustive scientific research to prove that the device is safe to use through, primarily, clinical trials. An Investigational Device Exemption is required prior to clinical studies. Its main function is to provide the groundwork as to what the studies will consist of and how they will be done. Finally, it will go through FDA approval.