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Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures

This guidance discusses ways for combination product sponsors to obtain feedback from FDA on scientific and regulatory questions. It outlines best practices for interactions between FDA and sponsors through application-based mechanisms and Combination Product Agreement Meetings (CPAMs). The guidance aims to enhance clarity and transparency regarding regulatory considerations for combination products.

  1. Determine if product is a combination product and identify the lead FDA center
  2. For general questions:
    • Contact OCP if uncertain about product classification or lead center
    • Contact lead center POC if already established
    • Contact lead center PJO if no POC assigned yet
  3. Choose appropriate feedback mechanism:
    • Use application-based mechanisms for scientific/technical questions
    • Consider CPAM for seeking formal agreements after previous feedback
    • Use dispute resolution for disagreements over FDA actions
  4. When submitting requests:
    • Identify product as combination product
    • Submit to appropriate lead center
    • Include comprehensive product information and supporting data
    • Provide clear, stage-appropriate questions
    • Follow center-specific submission processes
  5. Maintain communication through designated FDA POC
  6. Document all interactions and agreements reached with FDA
  7. Monitor for any changes that could affect validity of agreements reached

Key Considerations

Other considerations

  • 21 CFR 3.2: Definitions related to combination products
  • 21 CFR 3.2(e): Definition of combination product
  • 21 CFR 3.2(k): Definition of constituent parts

Original guidance

  • Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures
  • HTML / PDF
  • Issue date: 2020-12-04
  • Last changed date: 2021-01-20
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Combination Products, Biologics, Over-the-Counter Drugs
  • ReguVirta summary file ID: f25c55eaf331cb7f1b5d522fa5bb1c4d
This post is licensed under CC BY 4.0 by the author.