The Regulation of Sunglasses

THE REGULATION OF SUNGLASSES AND READING GLASSES by the U.S. FOOD AND DRUG ADMINISTRATION The United States Food and Drug Administration (FDA) has jurisdiction over the Federal regulation of medical devices made or sold in the United States. Two such medical devices are non-prescription sunglasses and reading glasses. Both devices are regulated as Class I medical devices. The FDA has exempted most Class I devices from filing a pre-market notification application, nor is FDA clearance required before marketing a Class I device in the U.S. Manufacturers and initial importers/distributors, however, must register their establishments with the FDA annually.4. Impact Resistant Lens and the Impact Resistant Statement a) Requirement for Impact Resistant Lenses Sunglasses and reading glasses must be impact resistant. The test for impact resistance is known as the “drop ball” test. Every glass lens, and a statistically significantly sample of a batch of plastic lenses, must be tested for impact resistance. The requirements and test methodology for impact resistance are set out at 21 CFR 801.410.

In addition of being certified I am a retired California State Licensed Optician and here is further important sunglass information in that state. The state of California bans the operation of a motor vehicle while wearing glasses having a temple width of one-half inch or more if any part of such temple extends below the horizontal center of the lens to interfere with lateral vision. California also requires that medical device manufactures physically located within the state file for a license from the state. And further the licensing process requires the state to inspect the facility unless an exemption can be applied.