FDA classifies phase-changing fiducial markers used in radiation therapy
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The Food and Drug Administration (FDA) has issued a final rule classifying “phase-changing fiducial markers” as Class II medical devices. These markers are small objects placed in or near a tumor to help doctors target radiation therapy more accurately during treatment.
Why it matters: This is a technical administrative change that clarifies the regulatory path for manufacturers making these specific markers, likely making it easier for them to bring new versions to market compared to more strictly regulated Class III devices.
Who it affects
- Medical device manufacturers producing radiation therapy markers
This action was taken by the FDA; readers should consult the Federal Register for the full technical details before relying on this information.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document