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

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

• DATES:
• ADDRESSES:
  • Electronic Submissions
  • Written Submissions
• FOR FURTHER INFORMATION CONTACT:
• SUPPLEMENTARY INFORMATION:
  • I. Background
    • A. Statutory and Regulatory Authorities
    • B. Regulatory History of the Device
  • II. Recommendation of the Panel
    • A. Identification
    • B. Recommended Classification of the Panel
    • C. Summary of Reasons for Recommendation
    • D. Risks to Health
  • III. Proposed Classification and FDA’s Finding
  • IV. Proposed Effective Date
  • V. Environmental Impact
  • VI. Analysis of Impacts
  • VII. Paperwork Reduction Act of 1995
  • VIII. Comments
  • IX. References
• List of Subjects in 21 CFR Part 886
• PART 886—OPHTHALMIC DEVICES

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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