Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
Key claim: The FDA is classifying the fludeoxyglucose F18-guided radiation therapy system into class II with special controls to assure safety and effectiveness while reducing regulatory burden.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Classifying the FDG F18-guided radiation therapy system as Class II with special controls establishes a 510(k) pathway for this molecular-imaging-guided radiotherapy technology, lowering the regulatory bar from premarket approval while requiring conformance to device-specific performance and labeling controls. For providers and manufacturers, this clarifies the market entry route for combining PET imaging biomarkers with radiation delivery, and continues the FDA’s pattern of using special-controls classification to routinize oversight of novel radiology devices.