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Latest Regulations
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ASC
DESC
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
Guidelines for Registration Review of Disposable Hydrocephalus Diverters (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-1
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Absorbable Surgical Sutures (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-2
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Disposable Intravenous Indwelling Needles (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-3
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration and Review of Disposable Hemodialysis Tubing (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-4
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Review of Hydrogel Dressing Registration (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-5
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Classification and Definition of Medical Devices for Myopia Control and Amblyopia Treatment (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20231113
Registration & Filing
2023-11-13
2023-11-13
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
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