FDA continues to seek input on LASIK

December 2, 2009

The FDA has reopened a public docket to receive information and comments about LASIK devices, it was reported in the Nov. 13 Federal Register. The agency will accept remarks until Nov. 15, 2010.

Silver Spring, MD

-The FDA has reopened a public docket to receive information and comments about LASIK devices, it was reported in the Nov. 13 Federal Register. The agency will accept remarks until Nov. 15, 2010.

“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,” the agency stated.

Comments may be submitted electronically at

www.regulations.gov

or in writing to the Division of Dockets Management (HFA–305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should include this docket number: FDA–2008–N–0488. Additional information may be obtained from Domini Bean, Center for Devices and Radiological Health, FDA, 10903 New Hampshire Ave., WO66 Room 4422, Silver Spring, MD 20993; phone 301/796–5733; or e-mail

domini.bean@fda.hhs.gov

.

The agency’s action follows the opening of a public docket from Sept. 12, 2008, to Sept. 14, 2009, during which time the agency sought information and comments on the post-market experience associated with the use of LASIK devices as well as information regarding potential barriers that may exist in providing the agency with feedback regarding LASIK procedures.

All comments submitted to the public docket are public information and may be posted on the FDA’s Web site,

www.fda.gov

, and also may be viewed in person in the Division of Dockets Management.