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FDA has received requests for more information on the Request for Designation (RFD) process. The RFD process is used to obtain a formal agency determination concerning which agency component will have lead responsibility for the premarket review and regulation of a combination product[1] , or for a drug, device, or biological product, when the jurisdiction is unclear or in dispute.
In an effort to improve the transparency of the jurisdiction process, capsular descriptions of selected jurisdictional decisions are provided below. In determining whether web-publication of a prior jurisdictional determination is appropriate for a particular product, FDA will take into account the extent to which the product can be suitably described, the extent to which the existence and description of the product or similarly described products has been made public, and related factors. In cases where it is not possible to adequately describe the subject of a jurisdictional decision and still protect trade secret and confidential commercial information, capsular descriptions of prior decisions will not be available.
It should be noted that these capsular descriptions describe prior FDA RFD decisions only and are not policy statements. The descriptions are intentionally general to ensure the protection of trade secret and confidential commercial information. Jurisdictional determinations are often influenced by subtle distinctions in a product’s composition, mode(s) of action, intended use and related factors, which are not fully reflected in the capsular descriptions. It is possible that a product that fits within one of the general capsular descriptions provided below might actually receive a different jurisdictional assignment, based on the consideration of factors not reflected in the brief capsular description provided.
Note: On June 30, 2003, FDA transferred some of the therapeutic biological products that had been reviewed and regulated by the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). CDER now has regulatory responsibility, including premarket review and continuing oversight, over the transferred products. It should be noted that some of the therapeutic biological products identified as being assigned to CBER at the time the RFD determination was made are now assigned to CDER. More information about the transfer is available at http://www.fda.gov/oc/combination/transfer.html .
[1]A combination product is assigned to an Agency center that will have primary jurisdiction for its premarket review and regulation. Under section 503(g) of the Act, the assignment of a “lead center” is based upon a determination of the “primary mode of action” (PMOA) of the combination product. For example, if the PMOA of a combination product is that of a biological product, then the combination product would be assigned to the Agency component responsible for premarket review of that biological product. Depending upon the type of combination product, approval, clearance or licensure may be obtained through submission of a single marketing application, or through separate marketing applications for the individual constituent parts of the combination product. The listings below identify the lead Center for each combination product based on the product’s PMOA, but in some cases, a marketing application to another Center may also have been requested.