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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