FDA Approves Shape-Shifting Markers to Guide Cancer-Killing Radiation Beams
Published Date: 7/29/2026
Rule
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 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.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 1 costs, 1 mixed.
Required clinical, lab, and labeling tests
To be in this Class II category, manufacturers must meet special controls that include clinical performance data (e.g., marker migration, visibility, tumor response interference, adverse events), animal performance data (toxicity and migration), non-clinical performance data (physical form maintenance, imaging visibility, interference with dose), biocompatibility, sterility and shelf-life testing, usability testing, and specified labeling content (materials/composition, adverse events summary, injection procedure, and shelf life).
Device moved to Class II
The FDA has classified the phase-changing fiducial marker for radiation therapy as Class II (special controls). This final order is effective July 29, 2026, and the classification was applicable on December 23, 2022. The FDA says this classification will provide reasonable assurance of safety and effectiveness and may enhance patient access by reducing regulatory burdens.
Device subject to 510(k) requirement
The phase-changing fiducial marker is subject to premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act and is not exempt under section 510(m). Manufacturers must therefore submit a 510(k) to market this Class II device.
Classification enables future 510(k) predicates
Because FDA classified this device via the De Novo process, the phase-changing fiducial marker can serve as a predicate device for future 510(k) submissions, allowing other sponsors to use the less-burdensome 510(k) pathway instead of De Novo or PMA for substantially equivalent devices.
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