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Comments may be made on the proposed order to reclassify surgical staplers and the draft guidance for labeling recommendations through June 24, 2019.Read More 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