Combination Products

Jurisdictional Information

The Office of Combination Products (OCP) issues classification and jurisdiction assignments for human medical products. The classification of a product determines the type of a product (drug, device, biological product, or combination product). Jurisdiction determines the FDA Center or Lead Center (CBER, CDER, or CDRH) that will regulate the product. For questions about the RFD process, you may contact OCP directly (using contact information at right of this page).  You can also find more information about the RFD process by clicking on this link: Request for Designation Document (RFD)

The links on the left of the page provide additional information about product classification and jurisdiction.

Contact FDA

301-796-8930
Fax:301-847-8619
Office of Combination Products

Food and Drug Administration

WO32, Hub/Mail Room #5129

10903 New Hampshire Avenue

Silver Spring, MD 20993

Page Last Updated: 03/19/2018
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