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Comprehensive Guide: FDA Regulations for Importing Sunglasses into the U.S.

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Understanding FDA Regulations for Importing Eyewear into the U.S.

August 31, 2023

Surprise! The United States Food and Drug Administration FDA categorizes sunglasses as Class I medical devices. This means that selling sunglasses in the U.S. without proper registration with the FDA is not only unlawful but also poses significant legal risks. Despite this initial shocker, once you comply with FDA requirements for registration, your product has access to a vast market across the entire United States.

We've compiled an extensive guide of what's required for eyewear including sunglasses and spectacles if you plan on selling them in the U.S.

Table of Contents

1. Overview of FDA Regulations for Selling Sunglasses

The FDA's regulations apply not only to eyewear manufacturers within the U.S., but also to foreign companies that produce or import products for distribution in the United States. This means that even if your company operates in China, Italy, or Japan, and you ship sunglasses into the U.S., you must ensure that both your establishment is registered with the FDA.

Furthermore, if you're an exporter shipping goods from a country like the U.K. to the U.S., regardless of where they were produced, these regulations apply equally. All companies selling glasses products in the U.S. need to designate and engage a United States Agent to act as their representative on American soil.

2. Understanding Drop Ball Test

A critical aspect of the FDA’s eyewear requirements is compliance with 21 CFR Part 801.410, which mandates that spectacles lenses meet impact resistance standards through a drop-ball test. Essentially, this involves dropping a steel ball weighing around 0.56 ounces from a height of approximately 50 inches onto the lens surface. The lens must not crack or shatter upon impact.

This safety regulation ensures that when eyewear users accidentally strike their lenses agnst a hard surface or face an impact force, there's minimal risk to their eyesight due to broken glass fragments. The ball's drop test is conducted by the lens manufacturer before they are sent out for distribution.

3. Consequences of Non-Compliance

Flure to adhere to FDA regulations could result in detention of your product at the U.S. port of entry and subsequent potential legal action, which can significantly impact sales and business reputation.


Navigating FDA requirements may seem daunting, but it's crucial for safeguarding your company from legal complications while ensuring consumer safety:

  1. Partner with an FDA-registered Manufacturer: Before you start collaborating on designs or manufacturing processes, ensure that your eyewear manufacturer is registered with the FDA.

  2. Confirm Lens Impact Resistance: Verify that every lens supplier provides drop ball test certificates to guarantee compliance with FDA standards before adding them to your product line. This information should be included in all U.S.-bound shipments.

  3. Establish a U.S. Representative Agent: If you're an international company, secure a United States Agent to represent you and address any issues that may arise during the registration process or ongoing operations.


By adhering to these guidelines and mntning compliance with FDA regulations for eyewear products inted for distribution in the United States, your business can avoid legal challenges while ensuring consumer safety.
This article is reproduced from: https://www.lensadvisor.com/blogs/news/fda-requirements-for-importing-eyewear-into-the-u-s

Please indicate when reprinting from: https://www.89vr.com/Eyewear_contact_lenses/FDA_Eyewear_Import_Regulations.html

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