Document ID: FDA-2008-N-0488-0001
Agency: fda
Document Type: Notice
Title: Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket
Posted Date: 2008-09-12T04:00Z

[Federal Register: September 12, 2008 (Volume 73, Number 178)]
[Notices]               
[Page 53028-53029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se08-68]                         

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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; Establishing a Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
opening of a public docket to receive information and comments on 
laser-assisted in situ keratomileusis (LASIK). We are opening the 
docket to gather additional information from interested persons on the 
post market experience associated with the use of LASIK devices.

DATES: Submit written or electronic information and comments by 
September 14, 2009.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug

[[Page 53029]]

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments or information to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Domini Cassis, Center for Devices and 
Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-2342, e-mail: 
domini.cassis@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 24, 2008 (73 FR 15530), FDA 
published a notice of a meeting for the Ophthalmic Devices Panel of the 
Medical Devices Advisory Committee (the panel). At the meeting on April 
25, 2008, the panel was asked to consider general issues concerning the 
post market experience with laser-assisted in situ keratomileusis 
(LASIK) procedures. Interested persons were invited to present data, 
information, or views, orally or in writing, to the panel regarding 
these topics. At the conclusion of the meeting, FDA requested that 
interested persons provide input on LASIK, including comments regarding 
tools the agency uses to improve patient safety, such as patient 
labeling, information on FDA's LASIK Web site, and other outreach 
initiatives.
    Using information gathered at the April 25, 2008, panel meeting, 
the agency has updated information contained on its LASIK Web site, has 
strengthened its post market surveillance activities, and is now 
seeking ways to better understand quality of life issues following 
LASIK procedures that may relate to safety and effectiveness of LASIK 
devices. At this time, the agency is interested in receiving public 
comments regarding the post market experience associated with the use 
of LASIK, as well as information regarding potential barriers that may 
exist in providing the agency with feedback regarding LASIK procedures. 
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) written or electronic 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.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA only through the FDMS at http://www.regulations.gov.

    Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21339 Filed 9-11-08; 8:45 am]

BILLING CODE 4160-01-S