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.
13 guides across 7 topics
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.
Registration, product codes, U.S. Agent designation, labeling and entry review all have to line up before the shipment lands. This is the order they happen in.
Most holds trace to registration, product code or labeling mismatches. The response window is short, and what you file next decides the outcome.
Part 801 content, a compliant UDI, a GUDID record and a controlled relabeling process all have to align before a device can be distributed.
General 3PL capability is not the same as device capability. These are the checks that separate the two before you sign.
Cold chain is a documentation discipline. Packaging qualification, monitors and excursion records are what protect the product and the file.
Registration is a filing; the obligations behind it are what get inspected. Here is what a device warehouse must actually maintain.
A recall is an information problem before it is a logistics problem. If the trace trail is complete, the retrieval is mechanical.
Thirty days is achievable because the workstreams run in parallel, not because anything is skipped. This is the sequence and your part in it.
Most NPI problems are transfer problems. What moves, what gets validated, and what gets frozen before scale-up decides the outcome.
Support is where complaints are discovered. Whether they are captured, assessed and reported correctly is a process decision made well before launch.