Federal Register
Notice: FDA is making available a document entitled Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers: Decorative, Non- Corrective Contact Lenses. It explains recently enacted legislation under which all contact lenses are deemed devices within the meaning of the Federal Food, Drug, and Cosmetic Act that require premarket approval or clearance by FDA and may be dispensed only upon a lawful prescription order by an eye care professional. To download this guidance, click here. To view this notice, click here.