FDA seeks to downgrade regulatory oversight of scleral plugs

January 25, 2013 by MassDevice staff

The FDA issues a proposed rule to exempt certain scleral plugs from the 510(k) regulatory process, deciding the devices don't need the extra safety and effectiveness controls as long as they're made of stainless steel.

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FDA officials this week issued a proposed rule that would downgrade the regulatory status of scleral plugs, devices used to temporarily close incisions made in the eye during surgical procedures.

The federal watchdog agency concluded that pre-market notification, or a 510(k) submission, is unnecessary to determine the safety and effectiveness of the devices, so long as they are made of surgical grade stainless steel with or without a gold, silver or titanium coating, according to a report in the Federal Register.

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The FDA currently requires 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, according to the FDA notice. 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.

The FDA agreed that the devices may not need 510(k) review, but stopped short of downgrading them to Class I status over concerns that such a downgrade would prevent the agency from exercising oversight of new materials.

The agency is gathering public comments on the potential downgrade until April 25, 2013.