June 4, 2019

FDA panel recommends reclassification of surgical staplers to Class II

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration’s General and Plastic Surgery Devices Advisory Committee on May 30 recommended that surgical staplers be reclassified from Class I to Class II devices. This would add premarket review and special controls to the devices.

The Committee said Class II regulation would offer a reasonable assurance of safety and effectiveness, and recommended simplifying proposed labeling and increasing surgeon training to improve outcomes. Some committee members also recommended a registry to track factors behind adverse events.

Comments may be made on the proposed order to reclassify surgical staplers and the draft guidance for labeling recommendations through June 24, 2019.

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