Sunglasses, eyeglass frames, eyeglass lenses, and magnifying glasses are medical devices that are exempt from the premarket notification 510(k) filed with the Food and Drug Administration (FDA). Although these devices are exempt from 510(k), they are subject to the applicable conditions set forth by the FDA.
Exporting U.S. eyeglasses products, sunglasses products are required to apply for FDA registration, eyeglasses (except contact lenses) and sunglasses belong to the medical device class I FDA registered product range, in addition, customs clearance is also required to provide eyeglasses lenses FDA Drip Ball proof (FDA21CFR801.410ImpactTest), therefore, eyeglasses exported to the United States need to have Therefore, glasses exported to the U.S. need to have FDA registration and FDA drop ball test certificate before they can be successfully cleared to the U.S. market.