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.
The agency in January proposed a reclassification of the devices, which are used to "provide temporary closure of a scleral incision during an ophthalmic surgical procedure," but the down-classification has been a long time coming.
The FDA had previously required scleral plugs to obtain 510(k) clearance before they’re allowed on the U.S. market, and 10 such devices have been cleared under the 510(k) pathway, 2 of them since the agency met with its Ophthalmic Devices Panel in January 1996 to discuss a potential downgrade.
The advisory panel recommended that the FDA downgrade stainless steel plugs to Class I, or general controls, because biocompatibility and sterilizability had already been established. Scleral plugs made of other materials, however, should remain in the 510(k) regulatory pathway and manufacturers should be required to demonstrate biocompatibility before winning FDA clearance, the panel added.