Direct to customer export of medical device (class I: prescription lenses + frame)

#1
Hello, we are a small, foreign manufacturer (EU) of a medical device (prescription lenses + special frames).
We are aware that we have to register and list our device with FDA, but we only sell it directly to the end user (via the e-commerce website).

Is direct import by a customer in the US even possible? I have read the FDA guidelines on who must register, but I'm not sure I interpret them correctly.
Would each customer (as an importer) also have to register and pay the fee?

Additional question:
We are the designer and the sole seller of our product through our website.
We are manufacturing the frame, but we use lenses made by other companies (popular lens brands).
Do all these companies have to be registered with the FDA, or just us?

I would be very grateful for anyone's help.
 
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#2
Yes, US customers can order online from sellers anywhere in the world and are not required to register with FDA, assuming they are either healthcare providers purchasing for use with their patients, or patients purchasing for their own use.

You can find information regarding who has to register with FDA here:

Device Registration and Listing

FDA has a lot of guidance available for medical device companies. If you are planning to sell to US customers, you might want to spend some time on its website:

Device Advice

The front page is currently dedicated to COVID-19, but if you look down the left-hand side of the page, you will find a number of topics that will be useful to you.
 
Last edited:
#3
Thank you for your reply.
I've read a lot about registering and medical devices on the FDA website, and I never got the impression that direct export could be a problem. This was suggested to us by an American company we contacted, which helps with registering and listing with the FDA.

They proposed to research the regulatory requirements of our product for quite a hefty fee.
It's a big expense for our company and I'm trying to find out as much as I can on my own.
 
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