FDA Classifies Preeclampsia Prognostic Test as Class II Device With Special Controls
July 01, 2026
July 01, 2026
WASHINGTON, July 1 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a rule classifying a prognostic test for the development or progression of preeclampsia as a class II medical device subject to special controls, a move the agency said provides reasonable assurance of the device's safety and effectiveness while reducing regulatory burdens for manufacturers.
The rule takes effect immediately, although the classification has app . . .
The rule takes effect immediately, although the classification has app . . .