As a European who had to deal with getting a medical devices approved both in the EU and in the US: mad respect for the FDA. There is lots of paperwork require

As a European who had to deal with getting a medical devices approved both in the EU and in the US: mad respect for the FDA. There is lots of paperwork required on both sides, but the difference is who accompanies the project. In the EU it's bureaucracts with zero domain knowledge, in the US it's domain experts who asked the right questions and were strict, but also genuinely helpful.