FDA Classifies Phase-Changing Radiation Therapy Marker as Class II Device
July 30, 2026
July 30, 2026
WASHINGTON, July 30 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final rule classifying phase-changing fiducial markers for radiation therapy as Class II medical devices subject to special controls, a step the agency said will provide reasonable assurance of safety and effectiveness while reducing regulatory burdens.
The order took effect on July 29, 2026, and applies retroactively to December 23, 2022. The device is defined a . . .
The order took effect on July 29, 2026, and applies retroactively to December 23, 2022. The device is defined a . . .