August 11, 2005

Senate Passes Bill to Regulate Plano CLs

WASHINGTON, D.C.--The U.S. Senate has passed a bill declaring that all contact lenses should be classified as medical devices. If the companion bill in the House of Representatives (H.R. 371) passes, consumers would require a prescription from a licensed eyecare professional to purchase cosmetic/plano CLs.

Plano contact lenses were categorized as Class II or Class III medical devices by the Food and Drug Administration (FDA) until two years ago. In April 2003, however, the FDA re-categorized non-vision correcting cosmetic CLs as cosmetic devices, which made their regulation much less stringent.

A number of eyecare organizations supported the measures including professional, patient-advocacy and industry groups.
Declaring that American Academy of Ophthalmology (AAO) members are "very pleased that the Senate gave this issue the attention it deserves and passed the bill," Catherine G. Cohen, AAO vice president for governmental affairs, said. "We are very optimistic that the House will take prompt action as soon as the August recess ends and send the legislation on its way to the President for his signature."

And Dan Garrett, senior vice president of Prevent Blindness America, commented, "Thanks to the combined efforts of professional organizations and volunteer groups like ours, we were able to take another step closer to protecting the eyes of all Americans."