Are Contact Lenses FDA Approved?

Contact lenses are regulated by the U.S. Food and Drug Administration (FDA) as medical devices. However, they are not "FDA approved" in the same manner as prescription drugs. Instead, most contact lenses receive FDA clearance through the 510(k) premarket notification process, which indicates that they are "FDA cleared."

FDA Classification and Clearance

The FDA classifies contact lenses as Class II or Class III medical devices and this depends on their intended use and associated risk level. Before these lenses can be marketed in the U.S., manufacturers must submit a 510(k) application demonstrating that their product is substantially equivalent to a legally marketed device. Once the FDA reviews and clears the application, the contact lenses can be legally sold in the U.S.

Importance of Purchasing FDA-Cleared Lenses

It's important to purchase contact lenses that have been FDA cleared to guarantee that they meet safety and efficacy standards. Buying lenses without FDA clearance, especially from unverified sources, can pose serious health risks, including eye infections and potential vision loss. Always obtain contact lenses through a valid prescription from a licensed eye care professional.