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Latest Regulations
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Title
ASC
DESC
Guiding Principles for Registration Review of Semiautomatic Chemiluminescence Immunoassay Analyzer (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-23
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Dental Comprehensive Treatment Machines (Revised in 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-24
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Examination of Hearing Aid Registration (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-25
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of X-ray Diagnostic Equipment (Class II) (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-26
Registration & Filing
2023-10-25
2022-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Medical Nebulizers (Revised in 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-27
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Positive Pressure Ventilation Therapy Machines (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-29
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Magnetic Therapy Products (Revised in 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-30
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Coagulation Analyzers (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-31
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Cold Light Sources for Medical Endoscopes (Revised in 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-32
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Salivary Acid Detection Kit (Enzyme Method) (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-33
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
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