federal_register: 2013-01447

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2013-01447 Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug Proposed Rule The Food and Drug Administration (FDA or Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to exempt the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and to continue to require premarket notification (510(k)) for all other scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The scleral plug is a prescription device used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. 2013-01-25 2013 1 https://www.federalregister.gov/documents/2013/01/25/2013-01447/medical-devices-ophthalmic-devices-classification-of-the-scleral-plug https://www.govinfo.gov/content/pkg/FR-2013-01-25/pdf/2013-01447.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to exempt the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver,...

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