FDA lowers regulatory oversight of scleral plugs for eye surgery
The FDA concludes that its less-stringent 510(k) regulatory pathway is sufficient to review the safety and effectiveness of scleral plugs, and that no premarket notification is needed for plugs made from surgical grade stainless steel.
The FDA this week issued its final rule on scleral plugs, down-classifying them to a lower-risk category of medical devices in need of less stringent review.
The FDA ruled to move the plugs to Class II, 510(k) premarket notification with special controls. The federal watchdog agency further exempted the devices from premarket notification as long as they are made from surgical grade stainless steel, with or without a gold, silver or titanium coating.