U.S. Food and Drug Administration

Office of Combination Products

Overview of the
Office of Combination  Products

Definition of a Combination Product

Frequently Asked Questions


Product Jurisdiction/Assignment of Combination Products:

Final Rule: Definition of the Primary Mode of Action of a Combination Product -Federal Register [PDF 4.91MB] (August 25, 2005 )


Requests for Comments


Guidance Documents and Procedures


Reports, Workshops and Presentations


What's New


Contact Us
We are interested in your comments and suggestions about combination products issues. Please contact:

Thinh Nguyen MS., Director
Office of Combination Products
Food and Drug Administration
15800 Crabbs Branch Way (HFG-3)
Suite 200
Rockville, MD 20855
(301) 427-1934
(301) 427-1935 fax
email: combination@fda.gov

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