Panel Backs CMV Device Down-classification

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 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.