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U.S. Department of Health and Human Services

Combination Products

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Jurisdictional Updates

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 on which Center will have lead responsibility for the premarket review and regulation of a combination product, or for a drug, device, or biological product, when the jurisdiction is unclear or in dispute. In an effort to keep stakeholders apprised of significant jurisdictional decisions, FDA plans to post a series of "jurisdictional updates" on this web page. It should be noted that jurisdictional updates report prior Agency decisions only and are not policy statements.

 

In determining whether web-publication of a jurisdictional update is appropriate for other products, FDA will take into account the current level of interest in the jurisdictional issue, the extent to which the class of products can be clearly described, the extent to which the existence and description of the class of 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 proprietary and trade secret information, jurisdictional updates will not be available.

 

Jurisdictional updates and related information can be viewed using the links at the left of this page and below. 

 

 

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