The vast majority of local antimicrobial susceptibility testing done in clinical microbiology laboratories utilizes commercial systems and devices. The manufacturers of these devices must submit a 510K to the FDA to get clearance of testing newly developed drugs. While this process can be arduous, time-consuming and expensive for the drug’s sponsor and the device manufacturer, it is critical in order to get a new product onto the test menu of the maximum number of laboratories as soon after regulatory approval as possible. Through MIPP, IHMA has unique capabilities and experience to coordinate this process between the sponsor and the diagnostic community to ensure that testing capabilities are achieved as soon as possible.