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Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements

This guidance clarifies when in vitro diagnostic (IVD) products should be labeled as Research Use Only (RUO) or Investigational Use Only (IUO). It addresses concerns about the distribution of unapproved/uncleared IVD products labeled as RUO/IUO but used for clinical diagnostic purposes, which can lead to unproven performance characteristics and inadequate manufacturing controls.

  1. Review current labeling to ensure compliance with RUO/IUO requirements
  2. Assess distribution practices to ensure consistency with RUO/IUO designation
  3. Evaluate technical support activities to ensure they don’t suggest clinical use
  4. Document evidence supporting research or investigational use status
  5. Implement controls to prevent clinical diagnostic use of RUO/IUO products
  6. Consider implementing user certification programs as additional control measure
  7. Consult with FDA when regulatory pathway is unclear
  8. Ensure compliance with all applicable manufacturing and quality requirements
  9. Establish process for monitoring and preventing inappropriate clinical use
  10. Review marketing and promotional materials to avoid suggesting clinical applications

Key Considerations

Clinical testing

  • Clinical diagnostic use of RUO/IUO products is not permitted
  • Products used in clinical diagnosis must be labeled “For In vitro diagnostic use” and comply with relevant IVD regulations

Non-clinical testing

  • RUO products are for laboratory research phase of development
  • IUO products are for product testing phase before commercial marketing
  • Testing should focus on design, limited-scale performance, and usability evaluation

Labelling

  • RUO products must be labeled: “For Research Use Only. Not for use in diagnostic procedures”
  • IUO products must be labeled: “For Investigational Use Only. The performance characteristics of this product have not been established”
  • Labels should serve as warnings against clinical diagnostic use
  • Clinical interpretive information or clinical significance discussions are not appropriate

Software

  • Software that is a standalone IVD or component/accessory must follow RUO/IUO labeling requirements when applicable
  • Can only be distributed for research or investigational use

Other considerations

  • 21 CFR 809.3: In vitro diagnostic products definition
  • 21 CFR 812: Investigational Device Exemption regulation
  • 21 CFR 809.10: Labeling requirements for in vitro diagnostic products

Original guidance

  • Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
  • HTML / PDF
  • Issue date: 2013-11-25
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Laboratory Tests, Premarket, IVDs (In Vitro Diagnostic Devices), Biologics, Investigational Device Exemption (IDE)
  • ReguVirta summary file ID: d79d5b0070634ccebea2f0ce6803c9f1
This post is licensed under CC BY 4.0 by the author.