UCM251544 - Guidance for Industry How to Write a Request...

Info iconThis preview shows pages 1–4. Sign up to view the full content.

View Full Document Right Arrow Icon

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
This is the end of the preview. Sign up to access the rest of the document.

Unformatted text preview: Guidance for Industry How to Write a Request for Designation (RFD) U.S. Department of Health and Human Services Food and Drug Administration Office of the Commissioner Office of Combination Products April 2011 Guidance for Industry How to Write a Request for Designation (RFD) For questions regarding this document, contact: Office of Combination Products (OCP) at 301-796-8930 or combination@fda.gov Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional copies are available from: Office of Combination Products Office of the Commissioner Food and Drug Administration WO32 Hub/Mail Room #5129 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 (Tel) 301-796-8930, (Fax) 301-847-8619 combination@fda.gov http://www.fda.gov/combinationproducts/ ii TABLE OF CONTENTS I. PURPOSE .............................................................................................................1 II. GENERAL INFORMATION REGARDING THE REQUEST FOR DESIGNATION PROCESS FOR NON-COMBINATION AND COMBINATION PRODUCTS...............................................................................2 A. What is a non-combination product? ............................................................................................2 B. What is a combination product? ....................................................................................................3 C. What is a Request for Designation?...............................................................................................3 D. When should an RFD be submitted?.............................................................................................4 E. Can I request a meeting with OCP to explain my product?........................................................4 F. How do I submit an RFD for a combination or non-combination product?..............................5 G. How promptly will FDA review my RFD?....................................................................................5 H. May I withdraw my RFD after submission?.................................................................................5 I. What if I disagree with OCPs jurisdictional determination?......................................................5 J. How can I contact OCP?..................................................................................................................6 K. Where can I find more information?.............................................................................................6 III. WHAT INFORMATION MUST I INCLUDE IN AN RFD?.......................6 A. What information must I include in my RFD?.............................................................................6A....
View Full Document

This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

Page1 / 21

UCM251544 - Guidance for Industry How to Write a Request...

This preview shows document pages 1 - 4. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online