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Latest Regulations

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Notice on the Second Public Solicitation of Opinions on the Guiding Principles for the Review of Human Factors Design Registration of Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231011 Registration & Filing 2023-10-11 2023-10-10
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Classification and Definition of in vitro Diagnostic Reagent Products Used in Flow Cytometers (Draft for Comments) and Compilation Explanation
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20231011-1 Registration & Filing 2023-10-11 2023-10-11
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines IVD
Guiding Principles for Classification and Definition of In Vitro Diagnostic Reagents for in situ Hybridization (Draft for Comments) and Compilation Explanation
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20231011-2 Registration & Filing 2023-10-11 2023-10-11
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines IVD
Guidelines for Registration and Review of Disposable Sterile Side Hole Blunt Needles (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-1 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Absorbable Hemostatic Products (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-2 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
α- Guiding Principles for Registration Review of Cyanoacrylate Medical Adhesives (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-3 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Absorbable Anti Adhesive Products for Abdominal and Pelvic Surgery (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-4 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Real World Research Design and Statistical Analysis of Medical Devices (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928 Registration & Filing 2023-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Corneal Topographer (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928-1 Registration & Filing 2023-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Intraperitoneal Endoscopic Surgery Systems Part 2: Animal Trial Decision Making and Requirements (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928-2 Registration & Filing 2023-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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