Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers; Decorative, Non-Corrective Contact Lenses; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers: Decorative, Non- Corrective Contact Lenses." This guidance document explains recently enacted legislation under which all contact lenses are deemed devices within the meaning of the Federal Food, Drug, and Cosmetic Act (the act). All contact lenses, including decorative, non-corrective contact lenses, require premarket approval or clearance by FDA and may be dispensed only upon a lawful prescription order by an eye care professional. Although this guidance document is being immediately implemented, the agency welcomes comments at any time in accordance with the agency's good guidance practices (GGPs).