Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?
Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun’s ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).
The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.