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.
Recommended Actions
- Engage FDA early in development process through joint meetings with relevant device and therapeutic product review divisions
- Plan for contemporaneous development of therapeutic product and companion diagnostic
- Determine appropriate regulatory pathway (PMA vs 510(k)) based on risk assessment
- Ensure clinical trials generate adequate data to establish safety and effectiveness of both products
- Prepare coordinated submissions for both therapeutic product and diagnostic device
- Develop compliant labeling addressing requirements for both products
- Consider IDE/IND requirements for investigational studies
- Plan for post-approval updates if expanding indications or uses
- Establish quality systems and controls appropriate for risk classification
- 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
- Contemporaneous development of therapeutic product and diagnostic device is preferred
- FDA generally won’t approve therapeutic product without approved/cleared diagnostic device
- Exceptions possible for serious conditions with no alternatives if benefits outweigh risks
- Early consultation with FDA recommended
- Separate marketing applications required for therapeutic product and diagnostic device
Relevant Guidances
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (Draft)
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
- Investigational In Vitro Diagnostic Devices Used in Therapeutic Product Clinical Trials (Draft)
Related references and norms
- 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
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