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Do I need to register with the FDA?

Hey, I'm importing into the US a device that is considered medical, even though marginally. It's not a new thing and has been in the market for a while, I private labelled it.

Our freight forwarder insists that they are not responsible for customs, and we're using some service called ClearIt as a Power of attorney. They require that our product and manufacturer be listed on FDA database.

I see that to register my company with FDA would be an annual 5k fee. Aren't there services that do this so I don't have to?

What are my options? Is this what FBA sellers and other retailers have to do?

submitted by /u/ApocalypseAce
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