A medical device that I can’t speak to much on because of IP is considered a combination product. It’s a diagnostic device which can accurately read small concentrations in the pico-scale. The device can use blood and or urine to detect let’s say tuberculosis. First the primary mode of action is to test concentration of blood of whatever agent in it against a standard. The department most suitable for this device will be CBER ( Center for Biologic Evaluation and Research). The pathway has several possibilities. Will have to do a BLA (Biologics License Application) . The biological product or diagnostic device is used in blood testing. It has to demonstrate Drug GMP compliance and/or Device QSR. It may go to Panel. The approval may be more heavily focuses on manufacturing facilities and issues. The regulatory path way is -> IND, (Phase 1,2,3) o pivotal Trials, BLA as stated before. However since this diagnostic is not new it can be considered a Class 1.