Business · 06/08/2026
FDA Classifies Fludeoxyglucose F18-Guided Radiation Therapy System into Class II with Special Controls
The FDA has classified the fludeoxyglucose F18-guided radiation therapy system into Class II, a category that requires special controls to ensure safety and effectiveness, aiming to enhance patient access to innovative devices while reducing regulatory burdens.
Original source language: Federal Register — Health and Human ServicesOpen original release →