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# Down Classify Proposal on Cytomegalovirus DNA Assay Devices
- URL: https://www.fdaweb.com/down-classify-proposal-on-cytomegalovirus-dna-assay-devices/
- Published: 2020-09-17T12:00:00.000Z
- Updated: 2026-09-14T16:29:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147670

*Federal Register* notice: FDA is proposing to reclassify Class 3 cytomegalovirus deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management into Class 2 (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “quantitative cytomegalovirus nucleic acid tests for transplant patient management” to identify these devices along with the special controls that it believes are necessary to provide a reasonable assurance of safety and effectiveness. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-20716.pdf?ref=fdaweb.com).