外贸预警 >技术贸易壁垒 >通报信息 >[G/TBT/N/USA/1647]

[G/TBT/N/USA/1647]

2020-09-23

中文标题:

微生物学设备;用于移植患者管理的巨细胞病毒脱氧核糖核酸定量检测装置的重新分类,更名为用于移植患者管理的巨细胞病毒核酸定量检测

英文标题:

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 (8 page(s), in English)

成员国:美国

通报日期:2020-09-22


内容概述:

Proposed amendment; proposed order; request for comments - The Food and Drug Administration (FDA or the Agency) is proposing to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "quantitative cytomegalovirus (CMV) nucleic acid tests for transplant patient management" to identify these devices along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for the device. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (general controls and premarket approval) to class II (general controls and special controls) and reduce the regulatory burdens associated with these devices as manufacturers of these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a premarket notification (510(k)) and obtain clearance, before marketing their device.