How are combination products assigned for review?
A combination product is assigned to an Agency Center or alternative organizational component that will have primary jurisdiction for its premarket review and regulation. Under section 503(g)(1) of the Act, assignment to a center with primary jurisdiction, or a lead center, is based on a determination of the “primary mode of action” (PMOA) of the combination product. For example, if the PMOA of a device-biological combination product is attributable to the biological product, the Agency component responsible for premarket review of that biological product would have primary jurisdiction for the combination product. A final rule defining the primary mode of action of a combination product was published in the August 25, 2005, Federal Register, and is available at http://www.fda.gov/oc/combination/. The final rule defines primary mode of action as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.” In some c
