FDA panel recommends reclassification of surgical staplers to Class II

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Comments may be made on the proposed order to reclassify surgical staplers and the draft guidance for labeling recommendations through June 24, 2019.