FDA Registration Process for Sunglasses

For exporting eyewear products such as sunglasses to the United States, FDA registration (510k exempt) is required. During customs clearance, in addition to FDA registration, a Drop Ball Test (also known as a Drop Ball Impact Test) must be provided.

The Drop Ball Test is a fundamental test conducted on the final batch of all related lenses before leaving the factory, to demonstrate that the batch of products exported to the United States meets the impact resistance standards and is qualified; typically, the test report is only provided when specifically requested by customs authorities, and generally, a manufacturer's Declaration of Conformity for impact-resistant lenses can serve as proof of compliance.

FDA 510k Exempt Registration, required documents:

1. Application Form

2. U.S. Agent

3. Product Name and Product Code (if applicable)

Note: Model numbers cannot be listed separately and must be included within the product name.

(5) Payment of FDA Medical Product Annual Registration Fee

An annual fee must be paid to the FDA each year. The amount of the annual fee varies and is subject to the FDA’s published rates;

If the product will no longer be sold in the United States, the annual fee does not need to be paid;

The completion time for registration depends on the processing time of the annual fee payment.

The annual fee for the following year is renewed between October 1 and December 31 each year, so October 1 also marks the start of product registration for the new fiscal year.

Important Notes

Regardless of registration status, the FDA logo must not be used on products; the FDA is not a certification mark, nor is it a certification body.