In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
This guidance provides principles for the codevelopment of an in vitro companion diagnostic device (IVD companion diagnostic) with a therapeutic product. It aims to assist therapeutic product sponsors and IVD sponsors in developing a therapeutic product and an accompanying IVD companion diagnostic to obtain contemporaneous marketing authorizations. The guidance describes general principles, regulatory requirements, clinical trial design considerations, and administrative aspects of the submission process.
This is a draft guidance. Not for implementation.
Recommended Actions
- Determine early if IVD companion diagnostic is needed for therapeutic product development
- Assess risk level of investigational IVD use and determine applicable IDE requirements
- Develop analytically validated test before pivotal clinical trials
- Design clinical trials to support both therapeutic product and IVD companion diagnostic claims
- Establish specimen collection and banking plan
- Consider modular PMA approach for IVD submission
- Coordinate review timelines between FDA centers
- Submit appropriate letters of authorization between sponsors
- Plan for manufacturing and BIMO inspections
- Ensure consistent labeling between products
- Establish post-marketing plans for both products
- Maintain ongoing communication between therapeutic product and IVD sponsors throughout development
Key Considerations
Clinical testing
- Clinical evidence to support IVD companion diagnostic use should be generated in major efficacy trials of therapeutic product
- Trial designs must support both therapeutic product and IVD companion diagnostic claims
- Consider prospective-retrospective approaches when appropriate
- Ensure adequate representation of markers in study population
- Establish appropriate cutoffs for IVD companion diagnostics
Non-clinical testing
- Analytical validation studies should be completed before using test in pivotal clinical trials
- Evaluate critical analytical performance characteristics of early prototype tests
- Consider specimen handling and storage requirements
- Plan for adequate specimen collection and banking
Labeling
- Labeling of therapeutic product and IVD companion diagnostic must be consistent
- IVD labeling should specify analytes referenced in therapeutic product labeling
- Claims should be supported by evidence from clinical trials
- Consider predictive, selection and monitoring claims based on trial design
Safety
- Assess risk level of investigational IVD use in clinical trials
- Consider IDE requirements based on risk assessment
- Address safety monitoring in clinical trials
- Report adverse events appropriately for both products
Other considerations
- Plan for contemporaneous marketing authorizations
- Consider modular PMA approach for IVD submissions
- Coordinate review timelines between centers
- Address manufacturing and BIMO inspection requirements
- Establish appropriate letters of authorization between sponsors
Relevant Guidances
- In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- Marketing and Distribution Requirements for Analyte Specific Reagents (ASRs)
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
Related references and norms
- 21 CFR Part 812: Investigational Device Exemptions
- 21 CFR Part 820: Quality System Regulation
- 21 CFR Part 803: Medical Device Reporting
- 21 CFR Part 809: In Vitro Diagnostic Products for Human Use
Original guidance
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development
- HTML / PDF
- Issue date: 2016-07-15
- Last changed date: 2019-05-14
- Status: DRAFT
- Official FDA topics: Medical Devices, Laboratory Tests, Premarket Approval (PMA), Drugs, 510(k), Premarket, IVDs (In Vitro Diagnostic Devices), Biologics
- ReguVirta summary file ID: 905f09f2b9c8cfc838543e61bfa3f716
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