Yes, I do have to agree with Fady Khalla post, it can varies depending on the application that this device is going to be used. As fady khalla mention, depending of the used of the device the risk could change. In addition to this, it got me thinking about combination of product. There are different type of combination product, Drug, biologic, and device. This product can be combine for example we could have Drug/Device, Biologic/device, Drug/biologic. Each could have different type of class depending on the risk of the combine product.