FDA to Reclassify Cytomegalovirus DNA Assays

September 28, 2020

The FDA has issued a proposed rule that would reclassify cytomegalovirus DNA quantitative assay devices for transplant patient management from Class III to Class II devices.

If finalized, manufacturers of these devices would no longer be required to submit a premarket approval application but could instead submit a 510(k) premarket notification to obtain clearance before marketing.

Since 2012, the FDA’s Center for Devices and Radiological Health has approved four premarket approval applications for the assays and said it has seen no recalls and a low incidence of adverse events linked to the products. The comment period on the proposed rule closes on Nov. 17.

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