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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Jurisdictional Information

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 medical product (e.g. combination product, drug, device, or biological product), when the jurisdiction is unclear or in dispute.

Jurisdictional updates and related information can be viewed below.

Jurisdictional Updates



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