An antibiotic-releasing hip stem is a combination product. If I was the regulatory person working with this product, the first thing I do would be to submit a request for designation to the office of combination products. They will determine which center has lead responsibility based on the mode of action and the device will then follow that center’s regulatory pathway. The primary role of action in this case providing structural support and stability to the patient. I would assume this makes it a device and therefore falls under CDRH. It would be a class II medical device. The claims would be that the device will provide structural support to patients to carry out daily activities, such as walking or running, while at the same time preventing infections by releasing antibiotics. I would want to perform mechanical testing (cyclic testing) on the device to see if it can sustain its function of supporting the patient physically long term. Also, I would do biocompatibility testing to see if the material used for the hip stem is biocompatible or not. The product does need an IDE so that it can be tested on humans before its marketed to the public.