Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff

Issue Date: November 25, 2013
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Laboratory Tests, IVDs (In Vitro Diagnostic Devices)
Status: Final

Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff

FDA is issuing this guidance document to provide the current thinking of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) on when in vitro diagnostic (IVD) products are properly labeled “for research use only” (RUO) or “for investigational use only” (IUO).

Download the Guidance Document