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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This is a draft guidance. Not for implementation.

  1. Determine early if IVD companion diagnostic is needed for therapeutic product development
  2. Assess risk level of investigational IVD use and determine applicable IDE requirements
  3. Develop analytically validated test before pivotal clinical trials
  4. Design clinical trials to support both therapeutic product and IVD companion diagnostic claims
  5. Establish specimen collection and banking plan
  6. Consider modular PMA approach for IVD submission
  7. Coordinate review timelines between FDA centers
  8. Submit appropriate letters of authorization between sponsors
  9. Plan for manufacturing and BIMO inspections
  10. Ensure consistent labeling between products
  11. Establish post-marketing plans for both products
  12. 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

  • 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
This post is licensed under CC BY 4.0 by the author.