DECEMBER 1, 2009--The U.S. Food and Drug Administration announced it is reopening a public docket to gather information and comments on LASIK devices, according to a notice published in the Federal Register. The FDA will accept comments and observations until Nov. 15, 2010.
"At this time, the agency is reopening the docket to continue to receive public comments," the notice said. "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 docket was previously open between Sept. 12, 2008, and Sept. 14, 2009.
Comments or information can be submitted electronically at www.regulations.gov. Written submissions can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The docket number - FDA-2008-N-0488 - must be included with submitted comments.
Comments submitted to the docket are public information and may be posted on the FDA Web site at www.fda.gov.
In early 2008, the FDA heard public testimony on low patient satisfaction stemming from poor visual outcomes and complications after LASIK.