Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only." This guidance document 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.