美国FDA 指导原则 如何准备工业指定前申请(Pre-RFD)指南 英文原版.pdfVIP

How to Prepare a Pre-Request for Designation (Pre-RFD) ____________________________________________________ Guidance for Industry Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register . Additional copies of this guidance are available from the Office of Combination Products website at /CombinationProducts/default.htm. For questions on the content of this guidance, contact the Office of Combination Products at combination@ An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0910-0845 (expires October 31, 2020). See additional PRA statement in Section VI of the guidance. U.S. Department of Health and Human Services Food and Drug Administration Office of Combination Products in the Office of the Commissioner February 2018 Contains Nonbinding Recommendations TABLE OF CONTENTS I. PURPOSE 3 II. BACKGROUND 3 III. GENERAL INFORMATION REGARDING THE PRE-RFD PROCESS FOR NON- COMBINATION AND COMBINATION PRODUCTS 4 A. What is a Pre-RFD? 4 B. When should I submit a Pre-RFD? 6 C. May I request a meeting with OCP to explain my product? 6 D. How do I submit a Pre-RFD for my product? 7 E. How promptly will FDA review my Pre-RFD? 7 F. May I withdraw my Pre-RFD after submission? 8 G. What