Zdrowie i gospodarka · 20/05/2024

FDA Reclassifies Ultrasound Cyclodestructive Device to Class II

The US Food and Drug Administration (FDA) is reclassifying the ultrasound cyclodestructive device from Class III to Class II, subject to premarket notification, and establishing special controls to ensure device safety and effectiveness. This reclassification is based on valid scientific evidence and allows manufacturers to submit a 510(k) submission for FDA clearance instead of a premarket approval application.