I would think this is a combination drug/device. The primary mode of action would be the function of the hip stem so structural support. This would be under the CDRH and be class 3. The regulatory pathway would like the one outlined on slide 36 and 31. The pathway in chronological order is RFD, “Pre” Pre-IDE, Pre-IDE, IDE, Pivotal Trials, and finally, PMA. I would claim that it provides structural support similar or better than the actual bone it is replacing. I would prove this by doing tensile tests as well as shock testing on a donated cadaver body bone (assuming some hospital provides this to companies) and the combination drug/device. I would also claim that is does not rust and do a ASTM corrosion test to determine this (when you cant wait a long period of time to test a material you have to create extreme conditions). I would also state that it fights infections and do a mouse model of some kind to demonstrate this. I would recommend Phase 1,2, and 3 clinical trials due to this being something that is going into someone’s body for a long period of time.