FDA wants to exempt certain scleral plugs from 510(k) process

01/27/2013 | MassDevice.com (Boston)

Certain scleral plugs, which are used to temporarily seal surgical eye incisions, would be exempted from the 510(k) clearance process under a proposal released by the FDA. The proposed rule, which is up for comment through April 25, applies to scleral plugs with surgical grade stainless steel construction that may be coated with titanium, silver or gold.

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MassDevice.com (Boston)

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