If you are a U.S.-based company and want to import any type of eyewear, whether it has prescription lenses or not, you must register with the FDA. We have prepared this guide to help you navigate the process.

Disclaimer: This is a guide created and managed by Badaboom and not an official resource endorsed by the FDA.

Why do I have to register?

• Sunglasses, Spectacle frames, Magnifying spectacles, Prescription Spectacle lens are considered medical devices by the FDA.
• Initial U.S. distributors (importers) of these devices must register their company with the FDA. If you don't, your goods may be detained at the U.S. port of entry.
• You can find more information on this here.

Will it cost me anything?

Yes, the fee to register your company with the FDA is $5,546 as of FY2021. This is an annual fee.

What do I need to register?

You need to have an incorporated company that has a Federal EIN number.

How do I register?

Here is a step-by-step guide on how to register your company with the FDA. You can find information on this directly from the FDA here.

Make registration payment and get PIN/PCN

You will first need to make you registration payment and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) from the Device Facility User Fee website.

1. Go to https://userfees.fda.gov/OA_HTML/furls.jsp and click 'I understand'.

   

2. Click 'New user? Please create a User Fee account'.

   

3. Select 'I am a new FDA User Fee Organization'. If you believe your organization has already registered, you can search for it by the other choices as well.