Medical Devices; Radiology Devices; Classification of the Phase-Changing…
July 29, 2026 6:11am
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special con...
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.
5-Second Takeaway
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls).
Why This Matters
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.
What Changed
- 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.
- The official abstract outlines the main policy action and its scope.
- The summary describes who is affected and the expected compliance path.
- The notice explains timing and implementation details for the change.
- Federal Register document: https://www.federalregister.gov/documents/2026/07/29/2026-15303/medical-devices-radiology-devices-classification-of-the-phase-changing-fiducial-marker-for-radiation
- Federal Register home: https://www.federalregister.gov/
Key Facts
- 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.
- The official abstract outlines the main policy action and its scope.
- The summary describes who is affected and the expected compliance path.
Key Numbers
- Federal Register document: https://www.federalregister.gov/documents/2026/07/29/2026-15303/medical-devices-radiology-devices-classification-of-the-phase-changing-fiducial-marker-for-radiation