FDA Classifies Glucose-Guided Radiation Therapy Device as Safe
Published Date: 8/6/2026
Rule
Summary
The Food and Drug Administration (FDA) is classifying the fludeoxyglucose F18-guided radiation therapy system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the fludeoxyglucose F18-guided radiation therapy system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Device Classified as Class II
The FDA has classified the fludeoxyglucose F18-guided radiation therapy system as Class II (special controls). The order is effective August 6, 2026, and the classification was applicable on February 1, 2023. FDA says this classification provides reasonable assurance of safety and effectiveness and will enhance patients' access by reducing regulatory burdens.
Creates Predicate for Future Devices
Because FDA classified this device via the De Novo process, this device type can serve as a predicate for future devices of the same type. Future sponsors may be able to use the less burdensome 510(k) process instead of De Novo or premarket approval, reducing regulatory burden for device sponsors.
Premarket 510(k) Notification Required
FDA states that fludeoxyglucose F18-guided radiation therapy systems are subject to premarket notification under section 510(k) of the FD&C Act because FDA has not determined this device type should be exempt under section 510(m).
New Special Controls: Testing and Labeling
FDA established special controls (codified at 21 CFR 892.5060) requiring manufacturers to perform specified analyses, design verification/validation, clinical and non-clinical performance testing, electrical and software verification/validation and hazard analysis, user training, and detailed labeling (including clinical test summaries and imaging agent instructions). These controls are part of the device's Class II requirements.
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