FDA Reclassifies Fludeoxyglucose F18 Radiation Therapy Systems
The agency moved the guided radiation therapy system to class II to reduce regulatory burdens and expand patient access [1].
The Food and Drug Administration has classified the fludeoxyglucose F18-guided radiation therapy system into class II.
By lowering the device class, the FDA intends to provide a reasonable assurance of safety and effectiveness while reducing regulatory burdens. This action will enhance patient access to beneficial innovative devices.
The FDA has not determined that these systems should be exempt from these notification requirements.
The order became effective August 6, 2026, though the classification was applicable as of February 1, 2023.