Federal Register Notice: FDA is making available a guidance entitled Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only. It is intended for manufacturers and distributors of “for research use only” (RUO) and “for investigational use only” (IUO) in vitro diagnostic (IVD) products and any other entities who label IVD products, as well as FDA staff. To download this guidance, click here. To view this notice, click here.