Research Use Only
According to the US Food and Drug Administration, “Research use only products are distinctive in that they are devices that may be used in research or investigations on humans that may eventually lead to their clearance or approval and may be marketed for and used in the research and investigation of other FDA-regulated products. The manufacturer of the research use only product is not necessarily the sponsor of a clinical investigation that uses the research use only product. The manufacturer of the product may legally distribute the product commercially without FDA premarket review as long as the distribution is only for investigational use. A manufacturer who labels its product research use only may provide and market it for research use.”
Irrimax Corporation is willing to work with a limited number of healthcare partners annually with unique research use only product. Please contact us if you are interested in a research initiative.