Federal Register #FDA-2026-N-7955

FDA Classifies Phase-Changing Fiducial Marker for Radiation Therapy as Class II Device

This notice announces the FDA's final classification of a new medical device type: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Nanovi A/S (submitted the De Novo request for BioXmark) - Product/Device Classified: - Phase-changing fiducial marker for radiation therapy - Single-use, sterile liquid material - Changes phase in situ when injected into tissue - Aids in radiation therapy by being visible on radiologic imaging - Notable Requirements: - Device is classified as Class II with special controls - Special controls include: - Clinical, animal, and non-clinical performance testing - Sterility validation - Usability testing - Specific labeling requirements - Codified under 21 CFR 892.5727 - No procurement, purchase quantities, or part numbers are included, as this is a regulatory classification, not a solicitation or award.

Description

The FDA is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). This device is a single-use, sterile liquid material that changes phase in situ when injected in tissue to aid radiation therapy treatment and is intended to be visualized using radiologic imaging modalities. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens to enhance patient access. Special controls include clinical, animal, and non-clinical performance testing, sterility validation, usability testing, and specific labeling requirements. The order is effective July 29, 2026, with classification applicable since December 23, 2022.

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