Requests for Designations: Combination Products reporting and records

Product Jurisdiction and Combination Products

OMB: 0910-0523

IC ID: 6241

Documents and Forms

Document Name Document Type
Form FDA 5003 Requests for Designations: Combination Products reporting and records Form and Instruction
FDA 5003 REQUEST FOR DESIGNATION Form FDA 5003 RFD 2020.pdf Form and Instruction
FDA 5004 Pre-REQUEST FOR DESIGNATION-INFORMAL SUBMISSION Form FDA 5004 Pre RFD 2020.pdf Form and Instruction
FDA 5005 Pre RFD - Supplemental Form FDA 5005 Pre RFD Supplement 2020.pdf Form and Instruction
GFI How to Write an RFD - April 2011.pdf Other-Agency Guidance
GFI How-to-Prepare-a-PreRFD - February 2018.pdf Other-Agency Guidance
GFI Requesting Feedback Combo Products - December 2020pdf.pdf Other-Agency Guidance