This guidance is intended to assist sponsors in obtaining a preliminary assessment from the U.S.
Food and Drug Administration (FDA or Agency) through the Pre-Request for Designation (Pre-RFD) process. The Pre-RFD process is available to provide informal, non-binding feedback regarding the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product. In addition, this informal process provides information about a non-combination or combination product’s assignment to the appropriate Agency Center (Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research
(CBER)) for premarket review and regulation. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP) and helps a sponsor understand the type of information to
provide in a Pre-RFD.
Additional information on topics outside the scope of this guidance may be found on our website
(at http://www.fda.gov/CombinationProducts/default.htm.) These topics include the definitions
of a non-combination and combination product, as well as information about the formal Request
for Designation (RFD) process.