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Scleral Plugs to Change FDA Classification

Posted on in Defective Medical Devices

In January 2013, according to the Federal Register, Volume 78, the Food and Drug Administration proposed for the first time that the scleral plug should be classified as a Class II (special controls) medical device. The development of a scleral plug was first announced in a medical journal in 1994, and was initially described as a device that “released drugs into the vitreous after being implanted and fixed at the pars plana.” The scleral plug, according to the Federal Register, is also a device “used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure.”

Now, 21 years later, the scleral plug is finally being classified as a Class II device. The only scleral plugs that will be exempt from premarket notifications, according to the Federal Register, are those made of surgical grade stainless steel, “with our without coating in gold, silver, or titanium.”

According to the Food and Drug Administration, Class I devices are subject to the lease regulation, while Class II devices “are those for which general controls alone are insufficient to assure safety and effectiveness.” Examples of special controls include, but are not limited to: postmarket surveillance, mandatory performance standards, and special labeling requirements. Yet even Class II devices do not require premarket approval—premarket approval is left for Class III devices. An example of a Class III device is a pacemaker.

And yet any implanted device, regardless of classification, comes with serious and inherent risks. If you or someone you know has been negatively affected by a Class II device such as a scleral plug—especially one that was initially classified as Class I—you may be eligible for compensation. Don't go through it alone. Contact an experienced defective medical device attorney today.

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