FR | Medical Devices | Ophthalmic Devices | Classification of the Scleral Plug | Regulatory Doctor

Federal Register: Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Federal Register: Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Proposed Rules]
[Pages 5327-5330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01447]

Medical Devices; Ophthalmic Devices; Classification of the 
Scleral Plug

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing 
to classify the scleral plug into class II (special controls), and 
proposing to exempt the scleral plugs composed of surgical grade 
stainless steel (with or without coating in gold, silver, or titanium) 
from premarket notification (510(k)) and to continue 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.

DATES: Submit either electronic or written comments by April 25, 2013. 
See section IV of this document for the proposed effective date of a 
final rule that may issue based on this proposal.

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