US import requirements for bench testing without 510k



Dear Experts,

There is a friend of mine who is in trouble - thought many be you could help.Their company is located in Europe, but they want to ship their product samples to the US for bio-compatibility testing, as they were unable to locate a bio-compatibility test lab in EU.

They do not hold a 510k and neither is their company or any branch/subsidiary located in the US. How can they ship the product samples to the US for bench testing. Please suggest. DO they need to do establishment registration, etc.

Thank you!

Ronen E

Problem Solver
1. They could try this lab - it's in Germany and they do biocompatibility.

2. I don't think they need any registration for merely doing biocompatibility testing in the USA. They just need to mark them very clearly and highlight in the accompanying paperwork that these are samples for bench testing ONLY.

Ronen E

Problem Solver
Thank you so much Ronen. I really appreciate your help.

You're welcome. I urge anyone who has ever been helped here to give something back to Elsmar and become a $ contributor. It can be as little as $10 or as big as you wish. Thanks!

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