WASHINGTON, July 29 -- Food and Drug Administration has issued a rule called: Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy.
The rule was published in the Federal Register on July 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: 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...