Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
Key claim: The FDA is classifying the phase-changing fiducial marker for radiation therapy as a class II medical device subject to special controls to assure safety and effectiveness while easing regulatory burden.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy 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 phase-changing fiducial marker for radiation therapy. 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 phase-changing fiducial markers as Class II under special controls establishes a defined regulatory pathway for these radiation-therapy targeting aids, letting future devices reach oncology practices via 510(k) clearance rather than premarket approval. For patients undergoing radiation treatment, this can broaden access to image-guided targeting tools while preserving safety review; for manufacturers, it lowers the compliance threshold for entering the market.