WASHINGTON, D.C.--The U.S. Food & Drug Administration (FDA)’s Ophthalmic Devices Panel met here last month to provide advice to the 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 hearings were held after investigation and research into the safety of certain contact lens care products, some of which were recalled from the U.S. market for various reasons in late 2006 and 2007.

According to the FDA’s Web site, 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. It 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 contact lens 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presented in the open public hearing included patient experiences, scientific data from published as well as unpublished studies, and specific recommendations from industry and professional organizations.

Transcripts, via written requests only, may be purchased from: 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).