Taking control of the IVD submission processTaking control of the IVD submission processJanuary 21, 2009
IVD companies face many challenges as they seek to commercialize new tests in the United States, such as issues relating to intellectual property, reimbursement, competition, manufacturing, and pricing. There is also another major hurdle: FDA. Sometimes manufacturers need to make multiple efforts to clear this hurdle, which delays market launch. Some IVDs fail to clear it at all.
Additional information available here.