Skip to nav Skip to content
Facebook Twitter LinkedIn Email

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.

This website uses cookies

We use cookies to ensure that we give you the best experience on our website. Cookies facilitate the functioning of this site including a member login and personalized experience. Cookies are also used to generate analytics to improve this site as well as enable social media functionality.