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NEW YORK – The US Food and Drug Administration issued a proposed rule Thursday that would reclassify cytomegalovirus DNA tests for transplant patient management. 

The rule is meant to offer more timely access to these tests by reclassifying certain CMV DNA quantitative assay devices from Class III to Class II and renaming them to quantitative CMV nucleic acid tests, as well as providing special controls to assure safety for the devices. Those special controls include certain labeling requirements, performance studies, and design validation activities. 

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