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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

  1. Contact OCP before submitting Pre-RFD if any questions about required information
  2. Follow the Pre-RFD screening checklist in Appendix A when preparing submission
  3. Provide concise but complete information about product description, intended use, mechanism of action
  4. Include clear product photos/diagrams
  5. Detail all components/ingredients and their purpose
  6. Clearly state intended claims and indications
  7. Consider requesting a meeting with OCP if needed to explain complex products
  8. Submit electronically if possible to combination@fda.gov
  9. Keep submission focused on information relevant for classification/assignment
  10. 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


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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