TBT BSN | Notification

Notification Detail :: G/TBT/N/USA/1647/Add.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management

Objective

Protection of human health or safety (TBT); Cost saving and productivity enhancement (TBT)

Product Covered

Cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management

Document Notification

Link to ePing

HSCODE

ICSCODE

11.040 - Medical equipment; 11.040 - Medical equipment; 11.100 - Laboratory medicine; 11.100 - Laboratory medicine

Keywords

Human health; Human health

Specific Regions

Description

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a post amendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification.This order is effective 23 October 2024.89 Federal Register (FR) 77448, Title 21 Code of Federal Regulations (CFR) Part 866_x000D_
https://www.govinfo.gov/content/pkg/FR-2024-09-23/html/2024-21616.htm_x000D_
https://www.govinfo.gov/content/pkg/FR-2024-09-23/pdf/2024-21616.pdfThis final amendment; final order and the proposed amendment; proposed order notified as G/TBT/N/USA/1647 are identified by Docket Number FDA-2016-N-2880. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2016-N-2880/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. _x000D_

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/USA/1647/Add.1

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