[Federal Register Volume 73, Number 178 (Friday, September 12, 2008)]
[Notices]
[Pages 53028-53029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21339]
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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:
[email protected].
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