The short answer
In the U.S., sunglasses and non-prescription reading glasses are medical devices. The maker needs FDA device establishment registration and device listing, and every pair must have impact-resistant lenses under 21 CFR 801.410, proven by the drop ball test. Most sunglasses and readers are Class I and exempt from 510(k).
The drop ball test
| Element | Requirement |
|---|---|
| Ball | Steel ball about 5/8 inch in diameter, about 0.56 ounce |
| Drop height | 50 inches onto the top (convex) surface, near the center of the lens |
| Fail | The lens cracks through its full thickness into two or more pieces, or any lens material visibly detaches |
| Who tests | The manufacturer — which includes the importer for resale; testing may be done in the country of origin |
| Sampling | Plastic and non-prescription lenses may be tested by statistical sampling, in uncut-finished or finished form; glass prescription lenses individually |
| Records | Test results, test methods and distribution records kept for 3 years |
Registration, listing and labeling
- 1Register the factoryDevice establishment registration with a U.S. Agent, renewed every October 1 to December 31; the FY2027 FDA fee is $13,785. See FY2027 user fees.
- 2List each device typeUsing the right product code for sunglasses or magnifying spectacles.
- 3Meet the quality system rulesCheck the classification regulation for which parts of the QMSR apply. See 510(k)-exempt devices.
- 4Label correctlyManufacturer or distributor name and place of business, and the lens power for readers. Do not claim protection you have not tested, such as “100% UV protection”.
- 5Keep drop ball recordsFor every production batch.
Example: sunglasses from Italy and readers from China
An Italian eyewear brand registers its factory with FDA, lists its sunglasses, and drop-ball tests a statistical sample of finished lenses from each batch, keeping the results for 3 years. A Chinese factory making +1.0 to +3.0 reading glasses for a U.S. retailer does the same, and the retailer, as importer, keeps copies of the test reports for each shipment.
Medical device registration and U.S. Agent $550 per year (FDA user fee separate). Device listing $50 per device. Medical device label review $550.
Frequently asked questions
Are sunglasses medical devices in the US?
Yes. Sunglasses and non-prescription reading glasses are medical devices and need registration, listing and impact-resistant lenses.
What is the FDA drop ball test?
A 5/8-inch steel ball weighing about 0.56 ounce is dropped 50 inches onto the lens. The lens must not crack through into pieces or shed material.
Who must perform the drop ball test?
The manufacturer, including the importer for resale. Testing can be done in the country of origin.
Do sunglasses need a 510(k)?
Most sunglasses and reading glasses are Class I and exempt from 510(k), but registration, listing and the impact-resistance rule still apply.
Sources
- 21 CFR 801.410 — Use of impact-resistant lenses in eyeglasses and sunglasses
- FDA — Class I and Class II device exemptions
- Federal Register — Medical device user fees for FY2027
Requirements checked on November 12, 2026. This article is general information, not legal advice.