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.
What You Need to Know? 👇
What is a Request for Designation (RFD) and when should I submit one?
An RFD is a written submission to FDA’s Office of Combination Products requesting determination of a product’s regulatory classification and/or which FDA Center should regulate it. Submit an RFD when your product’s classification or assignment is unclear, preferably before filing any investigational or marketing applications.
How long does FDA take to review an RFD submission?
FDA reviews RFDs for completeness within 5 business days and sends an acknowledgment letter with the filing date. The Agency must issue a designation letter within 60 calendar days of filing, or the sponsor’s recommendation automatically becomes the designated classification/assignment.
What are the key sections I must include in my RFD?
Your RFD must include sponsor identity, complete product description (composition, intended use, modes of action), manufacturing information, developmental work results, related products, and your classification/assignment recommendation. The submission is limited to 15 pages including attachments per 21 CFR 3.7(c).
How do I determine the Primary Mode of Action (PMOA) for my combination product?
PMOA is the single mode of action providing the most important therapeutic action. Consider the product’s intended use, how it achieves therapeutic effects, relative contribution of each component, duration of effects, and supporting data. If uncertain, use the assignment algorithm in 21 CFR 3.4(b).
Can I request a meeting with FDA before submitting my RFD?
Yes, you can request a pre-submission meeting if you believe it would help FDA understand your product better. Include an explanation of issues to be addressed. However, FDA generally won’t grant meetings after RFD submission due to mandatory review timeframes.
What happens if I disagree with FDA’s jurisdictional determination?
You can request reconsideration within 15 calendar days of receiving the designation letter. The request cannot exceed 5 pages and cannot include new information not in your original RFD. FDA will respond within 15 calendar days of receiving your reconsideration request.
What You Need to Do 👇
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