Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
fda-device · Food and Drug Administration · Rule · Published 2013-11-15 · Effective 2013-12-16 · 78 FR 68714
Document
Document number
2013-27365
Federal Register citation
78 FR 68714
CFR reference
21 CFR 886
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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.