Enter the U.S. market

More than half of FDA 510(k) clearances now go to companies outside the United States. We help international medical device companies get there with a clear plan and a U.S.-based team.

1. Step 1

   Choose the right FDA pathway

   Classification, product code and predicate search to decide between 510(k), De Novo or PMA.

2. Step 2

   Get FDA feedback early

   A Pre-Submission lets you confirm your testing plan with FDA before investing in it.

3. Step 3

   Close QMS and testing gaps

   Align your ISO 13485 system with FDA's QMSR and plan U.S.-ready verification and validation.

4. Step 4

   Qualify for reduced FDA fees

   Companies with revenue up to $100M can qualify for small business fees using a certification from their national tax authority.

5. Step 5

   Submit and respond

   eSTAR submission preparation and support with FDA Additional Information requests.

6. Step 6

   Register and launch

   U.S. Agent designation, establishment registration, device listing and importer guidance.