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The Office of Combination Products (OCP) assigns review responsibility for
combination products. 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 existing intercenter
agreements provide guidance on some combination product assignments. 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.
By submitting a "Request for Designation" (RFD), a company may obtain
a formal agency determination of a combination product’s primary mode
of action and of assignment of the lead agency center for the product’s
premarket review and regulation, or of the agency component that will have
jurisdiction for any drug, device, or biological product where such jurisdiction
is unclear or in dispute. The agency will make its jurisdictional determination
within 60 days of filing the RFD. The RFD process is outlined in 21
CFR Part 3 , and 21 CFR 3.7 outlines
the information required in an RFD submission. RFD submitters are encouraged to review the agency's guidance "How to Write a Request for Designation (RFD)," available at http://www.fda.gov/oc/combination/howtowrite.html 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 and FDA centers may also informally request assistance from OCP in working out difficult jurisdictional issues.
To facilitate our processing of your RFD, please send an electronic version
to combination@fda.gov in addition to the official request, which should be
mailed to:
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