FDA classifies surgical angle measurement tools as Class II medical devices
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Table of Contents
The Food and Drug Administration (FDA) has issued a final rule classifying intraoperative surgical angle measurement tools as Class II medical devices. These are tools used by surgeons during an operation to measure angles.
Why it matters: This is an administrative change that sets the regulatory requirements for how these specific surgical tools are reviewed and sold. It provides a clear path for manufacturers to follow.
Who it affects
- Medical device manufacturers who make surgical angle measurement tools
This action was taken by the Food and Drug Administration; 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