Medical devices; ophthalmic devices; classification of the scleral plug. Final rule.
The Food and Drug Administration (FDA or Agency) is classifying the scleral plug into class II (special controls), and exempting the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and continuing 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.
D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D013508:Ophthalmologic Surgical Procedures / Q000145:classification / Q000295:instrumentation*; D009885:Ophthalmology / Q000145:classification / Q000295:instrumentation*; D016639:Scleroplasty / Q000295:instrumentation*; D013525:Surgical Instruments / Q000145:classification*; D014481:United States