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.
- 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)