Document ID: FDA-2008-N-0488-0025
Agency: fda
Document Type: Notice
Title: Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Reopening of the Comment Period
Posted Date: 2009-11-13T05:00Z

[Federal Register: November 13, 2009 (Volume 74, Number 218)]
[Notices]               
[Page 58640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no09-67]                         

[[Page 58640]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0488]

 
Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ 
Keratomileusis (LASIK) Devices; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
reopening until November 15, 2010 of a public docket to receive 
information and comments on laser-assisted in situ keratomileusis 
(LASIK) devices.

DATES: The agency encourages interested parties to submit information 
and comments by November 15, 2010.

ADDRESSES: Submit electronic comments or information to http://
www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Domini Bean, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., WO66 Rm. 4422, Silver Spring, MD 20993, 301-796-5733, e-mail: 
domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 12, 2008 (73 FR 53028), FDA 
published a notice announcing the opening of a public docket to receive 
information and comments on the post market experience associated with 
the use of laser-assisted in situ keratomileusis (LASIK) devices, as 
well as information regarding potential barriers that may exist in 
providing the agency with feedback regarding LASIK procedures. 
Interested persons were invited to submit comments by September 14, 
2009. At this time, the agency is reopening the docket to continue to 
receive public comments. Information and comments submitted to the 
docket will assist us in identifying ways in which we can improve our 
public outreach efforts regarding the safety and effectiveness of LASIK 
devices.

II. Submission of Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. All 
comments submitted to the public docket are public information and may 
be posted to the FDA's Web site at http://www.fda.gov for public 
viewing. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 30, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-27222 Filed 11-12-09; 8:45 am]

BILLING CODE 4160-01-S