Working guides on entering the U.S. market and running operations once you are there. Each one stands alone, so you can start wherever your situation sits today.
3 of 13 guides
The FDA asks for a U.S. point of contact, not necessarily a subsidiary. Here is how to tell which structure your device program actually requires.
Office space is the line item everyone budgets for. The costs that sink the plan are compliance, staffing and the months before first revenue.
The Initial Importer carries real FDA obligations: complaint files, adverse event reporting and records open to inspection. Here is what that means in practice.