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.
Product Classification and Jurisdiction Guidance Documents
Assignment of Combination Products/ Product Jurisdiction Program
The Office of Combination Products (OCP) assigns review responsibility for combination products to a lead center (CBER, CDER, or CDRH). In accordance with section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 353(g)(l)), the agency is required to assign premarket review responsibility for combination products based on the product's "primary mode of action." The Office is also responsible for designating the component of FDA with primary jurisdiction for the premarket review and regulation of any product requiring a jurisdictional designation under 21 CFR Part 3. Such decisions may involve determinations of the regulatory identity of a product as a drug, device, biologic, or combination product; and the agency component that will have jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute.
A company may submit an RFD to obtain a formal agency determination of a combination product’s primary mode of action as well as assignment of the lead agency center for the product’s premarket review and regulation. A company may also submit an RFD to determine the agency component that will have jurisdiction for any drug, device, or biological product. The agency will make its jurisdictional determination within 60 days of filing the RFD. 21 CFR 3.7 outlines the information required in an RFD submission. FDA encourages RFD submitters to review the agency's guidance "How to Write a Request for Designation (RFD)," prior to submitting an RFD. The goal of this guidance is to help a sponsor understand the type of information FDA needs to determine the regulatory identity of a product as a drug, device, biological product, or combination product, and to assign the product to the appropriate agency component for review and regulation. This guidance reflects the final rule defining the primary mode of action of a combination product (PMOA Final Rule) published in the Federal Register on August 25, 2005. The PMOA Final Rule was effective November 23, 2005. Companies may also submit a Pre-RFD to request assistance from OCP to address jurisdictional issues. The Pre-RFD process is described in the Draft Guidance “How to Prepare a Pre-Request for Designation (Pre-RFD)."
To facilitate our processing of your RFD, please send an electronic version to firstname.lastname@example.org in addition to the official request, which should be mailed to:
Office of Combination Products
Food and Drug Administration
WO32, Hub/Mail Room #5129
10903 New Hampshire Avenue
Silver Spring, MD 20993
Tel: (301) 796-8930
Fax: (301) 847-8619
It is recommended that product sponsors contact OCP prior to submission of an RFD, if there are questions about the necessary information to be included in their submission.