Jurisdictional Information

The Office of Combination Products (OCP) issues classification and jurisdiction assignments for 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 the product will be regulated.  Classification and jurisdiction assignments can be made informally or formally. Informal assignment requests should be made by directly contacting OCP using the e-mail or phone contact information at the right of this page.  Formal assignment requests can be made by submission of a Request for Designation Document (RFD) to OCP.  FDA recommends that product sponsors contact OCP prior to submission of an RFD to discuss if this is the best approach.

 

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