Assistance Listing Devices in the Drug Compendia

IndustryDrug Compendia
ProblemA device manufacturer was launching an updated and enhanced version of their diabetes device. The new product was scheduled to have a different name, but the device manufacturer wanted to ensure that the different versions were distinguishable to prescribers in their e-prescribing systems. The device manufacturer was also seeking information on how their product would appear when compared to competitors.
PHSI SolutionPHSI reviewed the 510(k) approval letter, device user guide, and analogue device listings within the major drug compendia providers. Using the information gathered, PHSI hypothesized which products would share the same category with the newly-launched device. PHSI then drafted compendia submission forms for the device manufacturer and guided them through the compendia submission process.
ResultsThe device manufacturer’s product was successfully listed in all of the drug compendia. It was listed with unique naming that differentiated it from previous versions of the device, aiding in accurate prescribing and dispensing.