How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
This guidance explains the Pre-Request for Designation (Pre-RFD) process, which allows sponsors to obtain informal, non-binding feedback from FDA regarding: - The regulatory identity/classification of a human medical product as a drug, device, biological product, or combination product - The appropriate FDA Center assignment (CDER, CDRH, or CBER) for premarket review and regulation
Recommended Actions
- Contact OCP before submitting Pre-RFD if any questions about required information
- Follow the Pre-RFD screening checklist in Appendix A when preparing submission
- Provide concise but complete information about product description, intended use, mechanism of action
- Include clear product photos/diagrams
- Detail all components/ingredients and their purpose
- Clearly state intended claims and indications
- Consider requesting a meeting with OCP if needed to explain complex products
- Submit electronically if possible to combination@fda.gov
- Keep submission focused on information relevant for classification/assignment
- Be prepared for approximately 60-day review timeline once complete information is provided
Key Considerations
Non-clinical testing
- Optional to provide details of relevant testing that supports how the product works
- Study conditions/methods, controls, results and conclusions can be included if available
Labelling
- Must provide proposed use/intended use/indications for use statement
- Must provide instructions for use/conditions of use
- Must provide list of claims made or planned for the product
Biocompatibility
- Biocompatibility testing information is noted as typically not helpful for understanding how the product works
Other considerations
- Complete product description required including components/ingredients
- For biologically-derived materials, must describe processing and characterization
- Must explain how product works and all known methods/mechanisms of action
- Must explain how product will be marketed (configuration, packaging etc.)
- For combination products, should provide information on relative contribution of components
- No page limit but submissions should be concise and focused
- Can be submitted electronically or by mail
- FDA aims to provide feedback within 60 calendar days
Relevant Guidances
- How to Submit a Request for Designation (RFD) for Product Classification and FDA 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
Original guidance
- How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
- HTML / PDF
- Issue date: 2018-02-14
- Last changed date: 2020-01-21
- Status: FINAL
- Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
- ReguVirta summary file ID: cb58940e03eaf09c8c84289976673e3b
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