§ 892.5727 Phase-changing fiducial marker for radiation therapy.
(a)Identification. A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Clinical performance data under anticipated conditions of use must evaluate:
(i)Risk of marker migration in tissue during the course of radiation therapy through post-treatment follow-up;
(ii)The ability to visualize the marker to allow for adequate localization during the course of radiation therapy through post-treatme
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§ 892.5727 Phase-changing fiducial marker for radiation therapy.
(a) Identification. A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical performance data under anticipated conditions of use must evaluate:
(i) Risk of marker migration in tissue during the course of radiation therapy through post-treatment follow-up;
(ii) The ability to visualize the marker to allow for adequate localization during the course of radiation therapy through post-treatment follow-up;
(iii) Risk of device interference with tumor response assessment post-treatment; and
(iv) All adverse events.
(2) Animal performance data under anticipated conditions of use must evaluate device toxicity and the risk of marker migration.
(3) Non-clinical performance data under anticipated conditions of use must evaluate:
(i) Maintenance of physical form throughout the course of therapy and post-treatment follow-up;
(ii) Device visibility on one or more radiologic imaging modalities; and
(iii) Device interference with radiation dose delivery.
(4) Performance testing must demonstrate the patient-contacting components of the device are biocompatible.
(5) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(6) Performance testing must demonstrate device sterility and non-pyrogenicity.
(7) Usability testing must demonstrate that the device can be positioned as indicated based solely on reading the directions for use.
(8) The labeling must include:
(i) A detailed description of the device including materials and composition, chemical and physical properties, a description of the mechanism of the change of phase, and timeframe for achieving final state;
(ii) Summary of all reported device-related adverse events from clinical testing;
(iii) Information describing the injection procedure, including any use of image guidance, and the range of compatible injection needle gauges; and
(iv) A shelf life.
[91 FR 47790, July 29, 2026]