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How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment

This guidance provides recommendations for preparing a Request for Designation (RFD) submission to FDA's Office of Combination Products (OCP) to determine the regulatory identity of a product as a drug, device, biological product, or combination product, and to assign the product to the appropriate FDA component for review and regulation.

  1. Contact OCP before submission if clarification is needed
  2. Prepare RFD submission including:
    • Complete product description and composition
    • Intended use/indications
    • Mode(s) of action with supporting data
    • Primary mode of action determination for combination products
    • Manufacturing process description
    • Development/testing status and results
    • Classification and assignment recommendation
  3. Follow 15-page limit and required format
  4. Submit original RFD plus two copies to OCP
  5. Consider electronic submission in PDF format
  6. Include all required sections per 21 CFR 3.7(c)
  7. Provide comprehensive rationale for classification and assignment recommendations
  8. Reference relevant literature and data supporting mode of action claims

Key Considerations

Clinical testing

  • Brief reports of developmental work and clinical studies should be provided, particularly those establishing mode(s) of action
  • Status and results of clinical testing must be included

Non-clinical testing

  • Brief reports of animal testing results must be included
  • Status and results of preclinical studies should be provided, particularly those establishing mode(s) of action

Labelling

  • Proposed use/indications must be clearly stated
  • Schedule and duration of use must be specified
  • Dose and route of administration must be provided for drugs/biologics

Safety

  • Description of all known modes of action required
  • For combination products, primary mode of action must be identified with supporting rationale
  • Safety considerations are key factors in applying the assignment algorithm

Other considerations

  • 21 CFR Part 3: Product jurisdiction

Original guidance

  • How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment
  • HTML / PDF
  • Issue date: 2011-04-14
  • Last changed date: 2021-05-13
  • Status: FINAL
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: 76cca58e656844e9e692ceea337ae793
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