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.
Recommended Actions
- Contact OCP before submission if clarification is needed
- 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
- Follow 15-page limit and required format
- Submit original RFD plus two copies to OCP
- Consider electronic submission in PDF format
- Include all required sections per 21 CFR 3.7(c)
- Provide comprehensive rationale for classification and assignment recommendations
- 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
- Complete product description including composition required
- Manufacturing process description required
- Related products and their regulatory status must be described
- 15-page limit including attachments
- Sponsor’s recommendation for classification and assignment required
- Contact information and product identification details required
Relevant Guidances
- How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
- Classification of Products as Drugs or Devices: Interpretation and Determination Process
- Premarket Review Pathways for Combination Products
- Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures
Related references and norms
- 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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