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

The FDA is encouraging interested parties to submit information and comments by submitting electronic comments or information to http://www.regulations.gov. Or, comments may be submitted in written form and directed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should include the docket number: FDA-2008-N-0488.

In the Federal Register of September 12, 2008 the FDA had published a previous notice to receive 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. The FDA says its reopening of the comments will assist the agency in identifying ways in which it can improve its public outreach efforts regarding the safety and effectiveness of LASIK devices.

The FDA has demonstrated increased concern as of late over LASIK surgery, and recently announced a collaborative study would take place with the National Eye Institute and the U.S. Department of Defense to research "the potential impact on quality of life" on patients who have received LASIK surgery. The FDA also announced it is issuing warning letters to 17 LASIK ambulatory surgical centers following inspections that revealed inadequate adverse event reporting systems within the centers. (See DM 10507.)

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