Post

In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements

This guidance addresses In Vitro Companion Diagnostic Devices (IVD companion diagnostic devices) that are essential for the safe and effective use of a corresponding therapeutic product. It covers the development, approval process, and labeling requirements for both the diagnostic device and its associated therapeutic product.

  1. Engage FDA early in development process through joint meetings with relevant device and therapeutic product review divisions
  2. Plan for contemporaneous development of therapeutic product and companion diagnostic
  3. Determine appropriate regulatory pathway (PMA vs 510(k)) based on risk assessment
  4. Ensure clinical trials generate adequate data to establish safety and effectiveness of both products
  5. Prepare coordinated submissions for both therapeutic product and diagnostic device
  6. Develop compliant labeling addressing requirements for both products
  7. Consider IDE/IND requirements for investigational studies
  8. Plan for post-approval updates if expanding indications or uses
  9. Establish quality systems and controls appropriate for risk classification
  10. Maintain documentation of safety and effectiveness data throughout development process

Key Considerations

Clinical testing

  • Clinical performance and significance of the IVD companion diagnostic device should be established using data from clinical development program of therapeutic product
  • Both therapeutic product and diagnostic device can be studied in same investigational study if meeting IDE and IND requirements

Labeling

  • Therapeutic product labeling must specify use of FDA approved/cleared IVD companion diagnostic device
  • IVD companion diagnostic device labeling must specify therapeutic product(s) for which it is approved/cleared
  • Labeling of both products must be complete and consistent
  • Updates to labeling required when new uses/indications are approved

Safety

  • FDA will assess safety and effectiveness through premarket review
  • Risk-based approach to determine regulatory pathway (PMA or 510(k))
  • Safety measures may include REMS or postmarket requirements if needed

Other considerations

  • 21 CFR Part 812: Investigational Device Exemption regulations
  • 21 CFR Part 312: Investigational New Drug regulations
  • 21 CFR 809.10: Labeling requirements for in vitro diagnostic products

Original guidance

  • In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements
  • HTML / PDF
  • Issue date: 2014-08-06
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Drugs, Biologics
  • ReguVirta summary file ID: 1f5e3394982c0d1155adb8457ca38292
This post is licensed under CC BY 4.0 by the author.