How to Prepare a Pre-Request for Designation (Pre-RFD)
Introduction The FDA’s guidance “How to Prepare a Pre-Request for Designation (Pre-RFD)” provides structured recommendations for sponsors seeking preliminary feedback from the Office of Combination Products (OCP) on how their product should be classified (drug, device, biologic, or combination product) and to which FDA centre (e.g.,Although this is a U.S. FDA document, its lessons and […]