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        Jurisdictional Information

Jurisdictional Updates Home
          Combination Products
          Jurisdictional Information
          Jurisdictional UpdatesJurisdictional Information Jurisdictional Updates
  	
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    PrintFDA 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

Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff
	Jurisdictional Update: Breath Test Combination Products
	Jurisdictional Update: Dental Prophylaxis Pastes with Drug Components
	Jurisdictional Update: Drug - Device Combination Catheter Lock / Flush Solutions
	Jurisdictional Update: Drug-Biologic Combination Products
	Jurisdictional Update: Drug-Eluting Cardiovascular Stents
	Jurisdictional Update: Human Demineralized Bone Matrix
	Jurisdictional Update: Intercenter Agreements
	Jurisdictional Update: Metered Dose Inhalers, Spacers and Other Accessories
	Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

                                                                                  Content current as of:
      02/15/2018Jurisdictional Updates
 
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