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FDA Proposes Reclassification of Cytomegalovirus Quantitative Tests

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. 

Under FDA's classification hierarchy, Class III devices are considered to have the greatest potential risk to patients, while Class I devices have the lowest. Class II devices are somewhere in between the other two.

Under the proposed rule, manufacturers would no longer need to submit premarket approval applications for the tests but can submit premarket notifications and obtain 510(k) clearance before marketing the device. If the rule is finalized, the tests will be identified as prescription devices and must satisfy prescription labeling requirements for in vitro diagnostic products.

The rule would "decrease regulatory burden on industry," due to the 510(k)'s shorter premarket review timeline compared to a premarket approval application, FDA said.

FDA has approved four CMV DNA tests, including Roche's Cobas AmpliPrep/Cobas TaqMan CMV test, Qiagen's Artus CMV QS-RGQ kit, and the Abbott Realtime CMV test, the agency said. The tests measure CMV DNA levels in plasma or whole blood in transplant patients to determine active CMV infections or risk of developing a CMV infection, which can lead to organ rejection, organ disease, and death, according to the FDA. The tests can also be used to determine patient response during antiviral treatments to guide management decisions.