The Improtance of FDA Certification in Eyewear Industry

Raymio Eyewear having been deeply invovled in the eyewear industry for more than 15 year and we keep going on the path of progress for this unlimited potential market. 

As professional eyewear manufacturer, our products including sunglasses, optical frames and reading glasses and also have cooperated factories to produce ski goggles and safety goggles. We have FDA, CE and BSCI certificates.

The North America, as the biggest market in the global, FDA is the must be provided certificate when exporting the goods to North America especially US. It could tell that the importance and position of FDA certificate.

*What is FDA?

The full name of FDA is the US Food and Drug Administration, it was established in 1906 and is affiliated with the Department of Human Health and Hygiene Services and is authorized by Congress which is the federal government. Fda is the main administrative regulatory department in the United States for managing food, drugs, cosmetics, and it is also the highest law enforcement agency for food and drug supervision and management.

The FDA is responsible for the management of all food, drugs, cosmetics and radiation-related devices in the United States. It is not only collects and processes 80,000 product samples manufactured or imported within the united States and conducts inspections, but also dispatches thousands of inspectors every year to 15,000 factories overseas to confirm if their various activities comply with legal provisions of the United States.

* The importance of FDA Certificate in Eyewear Industry

FDA certificate has great significance to both eyewear manufacturer and customers. First, it could promote the healthy development of the eyewear industry and helps driving the eyewear industry towards to a more standardized and normalized direction, enhancing the overall competitveness of the whole inndustry. Especially the healthy competition among the eyewear manufacturers.

Second, FDA certificate ensures that it provides customers with a reliable basis for the products selection, making them more trusting  and choosing safe and qualified products.

Third, the products which have passed FDA certification have the quality and safety guaranteed, thus avoiding the risk of customers suffering the losses due to the purchasing inferior products, protecting the consumers' rights and interests.

* FDA Certification Process for Eyewear

The process of FDA certification of eyewear is relatively complex and mainly includes the following steps:

Understand the basic requirements of FDA: It is essential to understand the basic requirements of eyewear products before obtaining the FDA certification. The requirements are including the regulations on product design, product materials, manufacturing processes, product labels and instructions. These information could ensure that the eyewear products comply with the relevant regulations and standards of FDA certification.

Prepare the application materials: The relative and required documents and materials need to be prepared, which including the products manuals, technical specifications, test reports, quality management system documents, and to ensure the authenticity and accuracy of these materials to pass the review of FDA certification.

Submit application and pay the certification fee: The prepared application materials need to be submitted to the FDA and the manufacturer applicant pay the corresponding certification fees, usually the fee is really high. Then the applicant will select the appopriate type of certification and fill in the application forms.

Wait for the review and on-site inspection: FDA will review the application materials very stictly, including the safety, efficacy and quality of the products. And the on-site inspections may be conducted to vertify the production process and quality control of the prodcts. FDA may also ask some additional questions or requirements during the review and inspection process, the applicants need to be responded to and cooperated with promptly.

Performance tests: The eyewear manufacturer needs to send the products to a certified laboratory for various performance tests if the application is approved, including impact resistant tests and optical performace tests. The testing institution will inspect and test the samples to ensure that the eyewear products reach the standards of FDA' requirements.

Review certification report: FDA will review the test report which are submitted by the testing organization, including information like product specifications, product test results and certification conclusion. If it is passed, FDA will issue a certification to applicant.

Obtain certification: The eyewear manufacturer could sell their eyewear products to North America market or U.S. market legally after obtaining the FDA certification. However, FDA requires the eyewear manufacturer to supervise continuously, maintian the quality and safety of products. The regular testing and inspection will ensure the products meet the requirements of FDA.  What's more, the eyewear supplier need to update the product information and technical specifications in timely, to adapt the market changes and consumer demands, and to handle clients' complaints and feedback to enhance their satisfaction.

That's why the validity period of FDA certification is only one year.

* How to Choose Eyewear with FDA Certificate

Check the label of products: Please carefully examine the eyewear labels or instructions manual to look for the mark or relevant instructions of FDA certification.