FDA Action on CMV Diagnostics Represents Important Advance for Testing Access
The U.S. Food and Drug Administration’s order changing the classification for tests used to measure cytomegalovirus loads in transplant patients is an important step in improving and making more accessible a critical tool for patient care management.
IDSA has long called for the change from Class III to Class II for CMV and other tests that measure viral loads in transplant patients. This reclassification of these tests should help to increase the number of devices submitted to FDA for approval, ensuring greater availability of testing.
IDSA appreciates FDA’s attention to this need, and its assessment that the change will continue to provide a reasonable assurance of device safety and effectiveness.