# 2026-15303: FDA Approves Shape-Shifting Markers to Guide Cancer-Killing Radiation Beams

2026-15303, Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-07-29, effective 2026-07-29; PRIA reads it as touching household money (as of 2026-08-05).

- Canonical: https://policyrisk.com/federal-register/2026-15303
- As of: 2026-08-05
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-15303
- Title: Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 47788
- Published: 2026-07-29
- Effective: 2026-07-29
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-05

## In one line

FDA Approves Shape-Shifting Markers to Guide Cancer-Killing Radiation Beams

## 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.

## Effects PRIA read

- Device moved to Class II: benefit, medium. 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 e…
- Device subject to 510(k) requirement: mixed, medium. 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.
- Required clinical, lab, and labeling tests: cost, high. 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 maintena…
- Classification enables future 510(k) predicates: benefit, medium. 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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## Sources
- [2026-15303 on federalregister.gov](https://www.federalregister.gov/documents/2026/07/29/2026-15303/medical-devices-radiology-devices-classification-of-the-phase-changing-fiducial-marker-for-radiation)
- [2026-15303 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-07-29/pdf/2026-15303.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-15303 (as of 2026-08-05).