Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy

Title

Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy

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.

Posted

Jul 29, 2026

Comment period

Jul 29, 2026 – ?

Agency

Food and Drug Administration (FDA)

FR Doc

2026-15303

CFR

21 CFR Part 892

No comments yet.