The Ophthalmic Devices Panel met on June 10, 2008 to provide advice to the U.S. Food and Drug Administration (FDA) regarding modifications to preclinical and clinical testing guidance for contact lens care products, as well as modifications to product and patient labeling for these products. The Panel provided specific advice with regard to labeled warnings and directions for use. The Panel gave specific recommendations regarding disinfection efficacy, biocompatibility, and contact lens-care product solution compatibility testing. The Panel also provided advice regarding the classification of silicone hydrogel contact lenses and on various aspects of clinical study design.
The Open Public Hearing session gave the public an opportunity to provide input. A total of 18 speakers presented information, including patient representatives, academic researchers, practicing clinicians, professional society representatives and industry representatives. Information presented in the open public hearing included patient experiences, scientific data from published as well as unpublished studies, and specific recommendations from industry and professional organizations.
Contact: Karen Warburton, Executive Secretary, at 240-276-4238 or firstname.lastname@example.org
Transcripts may be purchased from: (written requests only)
Neal R. Gross & Company
1323 Rhode Island Ave., NW
Washington, DC 20008
(202) 234-4433 (voice), (800) 473-1433
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice), (301) 443-1726 (fax)