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Latest Regulations
1153 Results
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Title
ASC
DESC
Guiding Principles for Registration and Review of Stability Studies of In Vitro Diagnostic Reagents (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-4
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Technical Review of Hepatitis C Virus Nucleic Acid Testing Reagents (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-5
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Nucleic Acid Testing Reagents for Mycobacterium tuberculosis Composite Group (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-6
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Technical Review of Fully Automatic Chemiluminescence Immunoassay Analyzer (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-7
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Technical Review of Human Red Blood Cell Anti typing Reagent Registration (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-8
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Hepatitis B Virus Genotyping Testing Reagents (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-9
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Ultrasound Devices for Cosmetic Purposes (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20231123
Registration & Filing
2023-11-23
2023-11-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Hemodialysis Equipment (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231122-1
Registration & Filing
2023-11-22
2023-11-22
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of X-ray Flat Panel Detection Imaging Equipment (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231122-2
Registration & Filing
2023-11-22
2023-11-22
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Centrifugal Blood Component Separation Equipment (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231122-3
Registration & Filing
2023-11-22
2023-11-22
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
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