This is not a drill: what may come as a surprise to many is that the U.S. Food and Drug Administration (FDA) classifies sunglasses as Class 1 medical devices!
As a result, it is illegal to sell sunglasses in the U.S. without registering your products and company with the FDA.
Fortunately, once you complete your FDA registration and ensure that your products meet the relevant requirements, the entire United States market is open to you to market your products.
Check out our comprehensive list of requirements for selling glasses and sunglasses in the U.S.
Table of Contents
- What are FDA regulations for selling sunglasses in the U.S.?
- What is a drop-ball test?
- What happens if I don't abide by FDA regulations?
1. What are FDA regulations for selling sunglasses in the U.S.?
In the U.S., FDA regulations apply to sunglasses, spectacle frames, spectacles lenses and magnifying spectacles.
If you manufacture, import or distribute any of the aforementioned products in the U.S. you need to register your establishment with the FDA.
FDA regulations also apply to foreign companies: whether you manufacture your eyewear products in China, Italy or Japan, as long as your products enter the U.S., you will have to register your establishment with the FDA.
The same registration requirements apply to exporters: for example, if you manufacture in China but export to the U.S. even from outside China (such as the U.K., for example), you still have to register with the FDA. In addition. foreign companies must appoint a United States Agent who will act as your representative and contact person on U.S. soil.
Apart from registering your establishment with the FDA, all eyewear companies doing business in the U.S. must register their devices with the FDA and ensure their lenes meet the impact resistance requirements under 21 CFR Part 801.410. In other words, your lenses must pass the drop-ball test.
2. What is a drop-ball test?
Subjecting your lenses to a drop ball test ensures they comply with impact-resistant lens regulation, 21 CFR 801.410.
In a nutshell, the test involves dropping a 5/8 inch steel ball weighing approximately 0.56 ounces from a height of 50 inches onto your lens, and the lens cannot fracture.
From a safety perspective, passing the drop-ball test signifies your lenses are impact resistant and less likely to shatter and cause injury to the wearers' eyes.
The responsibility to conduct the drop-ball test lies with your lens manufacturer, so make sure they perform the test and provide results to you!
3. What happens if I don't abide by FDA regulations?
Failure to comply with FDA regulations may result in detenion of the device at the U.S. port of entry.
It sounds like a lot of things you need to worry about, but don't worry — just remember a couple of things:
- When looking for an eyewear manufacturer, ensure that they are registered with the FDA.
- When procuring lense for your optical frames, ensure that the lens factory produces drop ball tests certificates, which you should include in every eyewear shipment in and to the U.S.
- If you are a foreign company, find a United States Agent to act as your representative on the ground.