The FDA has released finalized guidance on the distribution of IVD products. IVD products for the lab research phase of development may be commercialized if they are labeled, “For Research Use Only [RUO]. Not for use in diagnostic procedures.” Investigational devices shipped for testing prior to commercial marketing must be labeled, “For Investigational Use Only [IUO]. The performance characteristics of this product have not been established.” The new guidance updates a 2011 draft and establishes that a manufacturer’s RUO or IUO product is not determined to be misbranded based on its actual use but only on the “totality of circumstances” regarding its distribution and use.

Source: raps.org