During this public health emergency associated with the COVID-19 pandemic, the Office of Combination Products (OCP) is requesting applicants/sponsors to submit RFDs (requests for designation) and Pre-RFDs (pre-requests for designation) electronically. To do so, applicants/sponsors may send RFDs and Pre-RFDs to email@example.com and identify the submission type (“RFD” or “Pre-RFD” as applicable) in the subject line of the email. If a sponsor makes a paper submission of an RFD pursuant to 21 CFR Part 3, or makes a paper submission of a Pre-RFD, OCP requests applicants/sponsors to also notify our mailbox at firstname.lastname@example.org. Finally, in lieu of telephone inquiries, please send all other information requests to our mailbox at email@example.com.
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.