FDA Classifies Chronic Kidney Disease Prognostic Test as Class II Device
July 24, 2026
July 24, 2026
WASHINGTON, July 24 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying a prognostic test for assessing chronic kidney disease progression as a Class II medical device with special controls, a move the agency said will provide reasonable assurance of safety and effectiveness while expanding access to innovative diagnostic technologies.
The order took effect July 24, 2026, although the classification has been a . . .
The order took effect July 24, 2026, although the classification has been a . . .