# Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
> **Food and Drug Administration** · Final rule. · Published 2013-11-15 · Effective 2013-12-16 · 78 FR 68714
## Document
- **Document number:** 2013-27365
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 78 FR 68714
- **CFR reference:** 21 CFR 886
- **Publication date:** 2013-11-15
- **Effective date:** 2013-12-16
- **HHS docket:** Docket No. FDA-2012-N-1238
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2013/11/15/2013-27365/medical-devices-ophthalmic-devices-classification-of-the-scleral-plug)
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