An antibiotic-releasing hip stem would fall under various categories including: device combined with a drug. This is due to the nature of the product. The device portion stems from the provider or carrier of the drug while the drug is the actual functional biologic attached the device. Therefore, an antibiotic-releasing stem would be a combination of both a device and drug. Now the primary mode of action for this product would be to regain hip mobility through providing the connection between the hip socket to the femur. This allows the user to walk. The overall high level goal of the hip stem is to allow functional mobility. That is the primary mode of action. Now, this device would fall under Class III. The product falls under this class due to the fact that the device can had serious adverse effects on the user that come originate from either the material contact interface or the antibiotic or pure mechanical shear. The claims that I would recommend for this product that the hip stem aids in mobility by supplementing the hip while fighting off infection through the use of antibiotics. Such reduction in infection wards off chances of the body rejecting the implant. Some studies that could be done in pre-clinical phase would be to test these implants or equivalent size variants in rats. Possibly running studies on how the antibiotic functions within mice/rat. Then upgrade to a system that is more comparable to that of a human being. I believe having an IDE would benefit this situation because it can be used to prove the safety and efficacy of the device. Definitiely studies both in-vitro and in-vivo can support the device development.