Federal Register #2026-15963

FDA Classifies Fludeoxyglucose F18-Guided Radiation Therapy System as Class II Device

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has issued a final regulatory order regarding a new medical device classification: - The Fludeoxyglucose F18-guided radiation therapy system is now classified as a class II medical device with special controls - This device combines emission computed tomography detection and a linear accelerator - Intended for use with FDA-approved fludeoxyglucose F18 to guide radiation therapy for cancer treatment - The classification is codified under 21 CFR Part 892 (Radiology Devices) - Special controls include requirements for: - Safety and effectiveness - Performance testing - Labeling - User training - Premarket notification (510(k)) is required for manufacturers - No specific OEMs or vendors are named in this regulatory action - This is not a procurement, solicitation, or award announcement—no products or services are being requested

Description

This document announces the final classification of the Fludeoxyglucose F18-guided radiation therapy system as a class II medical device with special controls by the Food and Drug Administration (FDA). The device combines an emission computed tomography detection system and a linear accelerator, intended for use with approved fludeoxyglucose F18 to guide radiation therapy for oncologic treatment. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The order is effective August 6, 2026, with the classification applicable from February 1, 2023.

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