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Dispute Resolution Process for Combination Product Review Timelines

This guidance outlines the process for submitting and resolving formal disputes regarding the timeliness of premarket review of combination products. It specifically addresses how applicants can present disputes when FDA does not review and act on premarket submissions within applicable timeframes.

  1. Document all timeline commitments and deadlines for the combination product review
  2. Monitor review timelines against applicable PDUFA/MDUFMA performance goals
  3. If timelines are not met:
    • First attempt resolution with reviewing division and office
    • Contact Center Ombudsman if needed
    • Submit formal dispute to OCP as last resort with all required information
  4. When submitting to OCP:
    • Provide complete documentation package
    • Be prepared for follow-up discussions
    • Monitor any new target dates established
  5. Maintain communication records with FDA throughout the dispute resolution process
  6. Contact OCP for follow-up if new target dates are not met

Key Considerations

Other considerations

  • 21 CFR 3.2(e): Definition of combination products
  • 21 CFR Part 312: Investigational New Drug Applications
  • 21 CFR Part 812: Investigational Device Exemptions
  • 21 CFR Part 814, Subpart H: Humanitarian Use Devices

Original guidance

  • Dispute Resolution Process for Combination Product Review Timelines
  • HTML / PDF
  • Issue date: 2004-05-03
  • Last changed date: 2024-08-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: 259f3267d161bf9f4befd7a87b696fd7
This post is licensed under CC BY 4.0 by the author.