Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
Information
Type
Rule
Regulated products
Medical Devices
Published
November 15, 2013
Last updated
November 15, 2013
Description
Document number 2013-27365. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)