Sponsors develop a series of clinical trials including Phase III trials that are randomized pivotal trials used in support of a drug label. If the drug label will state that the drug is to be used in only a subset of patients that are identified via an in vitro test (e.g. those above a pre-specified cutoff using a tumor marker assay) then the sponsor is expected to have the in vitro test come to CDRH Office of In Vitro Devices for review. Two centers would provide (coordinated) advice to a sponsor and then there would need to be a submission for CDRH and a submission for CDER (or CBER depending on the therapy).