Medical Devices; Ophthalmic Devices: Classification of the Eyelid Weight

Document ID: FDA-2013-N-0069-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Medical Devices
Federal Register Number: 2013-02862
CFR Citation: 21 CFR Part 886
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: February 08 2013, at 12:00 AM Eastern Standard Time
Start-End Page: 9349 - 9353
Page Count: 5
Comment Start Date: February 8 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: May 9 2013, at 11:59 PM Eastern Standard Time

Attachments:

Ref 10 Seiff_ S_ R_ J_ H_ Sullivan_ L_ N_ and J. Ahn_ Pretarsal Fixation of Gold Freeman Weights in Facial Nerve Palsy

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Ref 11 Kartush_ J_ M_C_ J. Linstrom_ P_ M_ McCann_ and M_ D_ Graham_ Early Gold Weight Eyelid Implantation for Facial Paralysis

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Ref 13 Silver_ A_ L_ R_ W_ Lindsay_ M_ L_ Cheney_ and T_ A_ Hadlock Thin_Profile Platinum Eyelid Weighting A Superior Option in the Paralyzed Eye

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Ref 14 Schrom_ T_ A_ Loch_ M. Ho_ lzl_ and H_ Scherer_ Abstract Evaluation of a New Lid Implant for Rehabilitation of the Paralyzed Eye

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Ref 15 Zwick_ O_ M_ and S_ R_ Seiff_ ‘Supportive Care of Facial Nerve Palsy with Temporary External Eyelid Weights

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Ref 16 Williams_ Z_ R_ and J_ V_ Aquavella_ Management of Exposure KeratopathyAssociated with Severe Craniofacial Trauma

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Ref 17 Gautam_ P_ R_ K_ Adhikari_ and B_ R_ Sharma_ A Profile of Eye_Lid Conditions Requiring Reconstruction Among the Patients Attending an Oculoplasty Clinic in Mid-Western Region of Nepal

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Ref 18 Heier_ J_ S_ R_ W_ Enzenauer_ S_ F_ Wintermeyer_ M_ Delaney_ and F_ P_ LaPiana, ‘‘Ocular Injuries and Diseases at a Combat Support Hospital in Support of Operations Desert Shield and Desert Storm,

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Ref 19 Mader_ T_ H_ J_ V_ Aragones_ A_ C_ Chandler_ J_ A_ Hazlehurst_ J_ Heier_ J_ D_ Kingham and E_ Stein Ocular and Ocular Adnexal Injuries Treated by United States Military Ophthalmologists During Operations Desert Shield and Desert Storm

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Ref 1-Transcript from FDA Ophthalmic Devices Panel Meeting January 13 and 14 2000

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Ref 2 Seiff_ S_ R_ M_ Boerner and S_ R_ Treatment of Facial Palsies With Carter External Eyelid Weights

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Ref 20 Morley_ M_ G_ J_ K._Nguyen_ J_ S_ Heier_B_ J_Shingleton, J_ F_ Pasternak, and K_S_ Bower_ Blast Eye Injuries A Reviewfor First Responders

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Ref 21Blozan_ C_ F_ and S_ A_ Tucker_ Premarket Notifications The First 24,000

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Ref 22 U_S_ Department of Commerce Bureau of Economic Analysis, National Income and Product Accounts Table 1_1_9 ImplicitPrice Deflators for Gross Domestic Product

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Ref 23 Geiger_ D._R_ FY 2003 and 2004 Unit Costs for the Process of Medical Device Review

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Ref 3 Neuman_ A_ R_ A_ Weinberg_ M_ Sela_ I_ J_ Peled_ and M_ R_ Wexler_ The Correction of Seventh Nerve Palsy Lagophthalmos With Gold Lid Load 16 Years Experience

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Ref 4 Kelley_S_ A_ and D_ T_ Sharpe_ Gold Eyelid Weights in Patients With Facial Palsy

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Ref 5 Jobe_ R_ Gold Lid Loads

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Ref 6 Pickford_ M_ A_ T_ Scamp_ and D_ H_ Harrison Morbidity After Gold Weight Insertion Into the Upper Eyelid in Facial Palsy

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Ref 7 Patel_ B_ C_ P_ Flaharty_ and R_ L_ Anderson ‘Morbidity After Gold Weight Insertion

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Ref 8 Jobe_ R_ The Use of Gold Weights in the Upper Eyelid

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Ref 9 Chapman_ P_ and B_ G_ Lamberty_ Results of Upper Lid Loading in the Treatment of Lagophthalmos Caused by Facial Palsy

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Ref12 Townsend_ D_ J_ Eyelid Reanimation for the Treatment of Paralytic Lagophthalmos Historical Perspectives and Current Applications of the Gold Weight Implant

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See Reference 13

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Comments

   
Total: 2
American Optometric Association - Comment
Submitter: Ronald    Posted: 05/20/2013     ID: FDA-2013-N-0069-0002

May 09,2013 11:59 PM ET
MedDev Corporation - Comment
Submitter: Eileen    Posted: 05/20/2013     ID: FDA-2013-N-0069-0003

May 09,2013 11:59 PM ET

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