E8-21339. Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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: [e-mail].

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.