On November 9, 2005, section 520(n) was added to the Federal Food, Drug, and Cosmetic Act (the Act) by Public Law 109-96 to establish that all contact lenses are devices under section 201(h) of the Act. Because all contact lenses are now regulated as devices, including decorative, non-corrective contact lenses intended only to change the normal appearance of the eye, all contact lenses must be the subject of a cleared premarket notification (510(k)) or an approved premarket approval application (PMA) before they may be legally marketed. Additional device authorities, such as the requirement that lenses be dispensed only upon a prescription order, also apply. This guidance explains how section 520(n) affects FDA’s regulation of non-corrective contact lenses intended to change the appearance or color of a normal eye for decorative use.

http://www.ftc.gov/os/2004/01/040130contactlensrulefrn.pdf