Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: FDA classifies Fludeoxyglucose F18-Guided Radiation Therapy System as class II device, (Aug 7, 2026)

By WK Editorial Staff

The order establishes special controls, testing, labeling, and training requirements for manufacturers seeking to market the technology.

The Food and Drug Administration (FDA) issued a final order classifying the fludeoxyglucose F18-guided radiation therapy system as a Class II medical device subject to special controls, concluding that the classification provides a reasonable assurance of the device’s safety and effectiveness. The device combines positron emission tomography (PET) imaging with a linear accelerator to guide radiation therapy treatment using approved fludeoxyglucose F18. FDA stated that the classification may improve patient access to innovative treatment technologies by reducing regulatory burdens associated with automatic Class III designation. The order codifies the device classification and establishes clinical, non-clinical, software, labeling, and training requirements intended to mitigate identified risks and support safe use of the technology (Final Rule, 91 Fed. Reg. 50708 (Aug. 6, 2026)).

Dates. This order is effective August 6, 2026. The classification was applicable on February 1, 2023.

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