FDA Considers a Downgrade of the Regulatory Status for Scleral Plugs
Published date : 28 January 2013
Article date : 28 January 2013
Massdevice reports that the FDA has issued a proposed rule that would exempt certain scleral plugs from the 510(k) regulatory process after deciding that the devices don't need the extra safety and effectiveness controls where they are made of stainless steel. The plugs are used to temporarily close incisions made in the eye during surgical procedures.
They say that the FDA has 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.
The advisory panel recommended that the FDA downgrade stainless steel plugs to Class I, or general controls, because biocompatibility and sterilisability had already been established.
The agency is gathering public comments on the potential downgrade up until April 25, 2013.
Source: Massdevice, 25 January 2013
