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    Request for Designation

    Formal mechanism to obtain a binding FDA decision on which Center will regulate a product.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    An RFD is submitted to the Office of Combination Products to determine the classification of a product (drug, device, biologic, or combination) and assign the lead FDA Center based on primary mode of action.

    What this means in practice

    Often used early in development for novel combination products to remove ambiguity about the regulatory pathway and applicable cGMP requirements.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    FDA·2European Commission·1
    1. 1
      How to Submit an RFD
      Needs review
      FDAfda.gov
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.