FDA Classifies Coagulation System for Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients as Class II
May 09, 2025
May 09, 2025
WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has finalized the classification of the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients into Class II (special controls). The FDA has determined that this classification will provide a reasonable assurance of the safety and effectiveness of the device, ultimately enhancing access to beneficial innovations while reducing regulator . . .