First of all, thank you djr32 for putting up this article. It’s very interesting to do research in developing artificial organs from the lab grown biological organs. I completely agree with the above posts that artificial organs would be a Class III device. This would mean getting a Premarket Approval before launching the product in the market. Class III device also requires Investigational Device Exemption (IDE) because it’s a “significant risk” device. In the beginning, the company would have to do many clinical trials to prove that the device will be safe. Investigational Device Exemption (IDE) will assist before clinical trials to layout the steps and how the study will be conducted. Lastly, it will go through FDA approval before releasing in the market.