Contact Lenses

The US FDA has relaxed its policy on the regulation of noncorrective contact lenses (also called zero-powered, plano, decorative or cosmetic lenses), while at the same time acknowledging that these lenses can cause a variety of eye injuries1,2. Up until recently, the FDA's policy was to regulate such contact lenses as medical devices, but now the agency has decided that they are cosmetics under the Federal Food, Drug, and CosmeticAct because they are `articles... applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance'. In an April 2003 Federal Register notice, the FDA supports its new position by stating that `The fact that contact lenses are `devices' in the colloquial sense does not preclude cosmetic status under the act... Moreover, the fact that a product is intended to come into contact with the eye does not make it ineligible for cosmetic regulation... Provided they are not marketed with claims... that they effect physical or physiological change, decorative contact lenses are properly regulated as cosmetics under the act.'

According to the FDA, although only corrective contact lenses are required to comply with medical device regulations, sponsors may voluntarily include noncorrective contact lenses in their pre-market notifications [510(k)] as...