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Latest Regulations
1789 Results
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Title
ASC
DESC
Guiding Principles for Registration Review of Medical Catheter Fixation Devices (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-12
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 Respiratory Masks (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-13
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 Microscopic Manipulators for Assisted Reproduction (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-14
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 Medical Sodium Hyaluronate Wound Dressings (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-15
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 Electrolyte Analyzers (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-16
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 the Registration and Review of Glucose Testing Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-17
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Gram Negative Bacteria Identification Reagents (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-18
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration Review of Pyruvate Testing Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-19
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
α- Guiding Principles for Registration and Review of Amylase Detection Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-20
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
α- Guiding Principles for Registration and Review of Hydroxybutyrate Dehydrogenase Testing Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-21
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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