The United States Food and Drug Administration, a federal watchdog agency, proposed a new rule that would downgrade regulation of scleral plugs. Scleral plugs are used to close incisions in the eye during surgical operations. According to the FDA, some scleral plugs may qualify for exemption from 510(k) regulatory procedures, based on their material composition.
In a notice, the FDA stated that a traditional pre-market notification (a 510(k) notification) is not required to determine the efficacy and safety of scleral plugs. As long as a scleral plug is made of pure surgical-grade stainless steel, it will not need to go through the regular regulatory process. However, the reduced regulatory requirements will not apply to scleral plugs that include a silver, titanium or gold coating.
Under current regulatory procedures, a company that makes scleral plugs must obtain a 510(k) approval prior to U.S. market entry. As of now, 10 devices have been approved through this process. In 1996, the FDA met with the Ophthalmic Devices Panel to discuss the benefits and disadvantages of a regulatory downgrade for the device class.
The Ophthalmic Devices Panel recommended a downgrade to general controls (Class I) for the stainless steel plugs since sterilizability and biocompatibility have been previously established. However, devices made from other materials must receive FDA clearance through the traditional regulatory processes.
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