> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Panel Backs CMV Device Down-classification
- URL: https://www.fdaweb.com/panel-backs-cmv-device-down-classification/
- Published: 2016-11-16T12:00:00.000Z
- Updated: 2026-09-14T21:48:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137354

Members of the FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended 11/9 down-classification of quantitative cytomegalovirus (CMV) viral load devices from Class 3 to Class 2\. Meeting [minutes](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM529382.pdf?ref=fdaweb.com) indicate that committee members said the down-classification would require development of carefully crafted special controls covering device labeling, standardization, manufacturing information, and clinical performance studies.

The committee also discussed appropriate initial classification for viral load devices for Epstein-Barr virus (EBV) and BK virus. Members said that EBV brings much more scientific uncertainty compared to BK and CMV, and is not likely to support Class 2 (*de* novo) classification were a submission to be filed. Members supported *de novo* status or possible expedited access approval as a PMA for a submission for BK virus. The minutes say that the clinical importance of the BK virus in the kidney transplant setting was emphasized.