A 510(k) exemption removes premarket notification only. Registration, listing, AofC codes, UDI and labeling still decide whether exempt devices clear FDA.
Under EPCA the importer is the manufacturer. How 19 CFR 12.50 lets CBP refuse uncertified appliances, HVAC and lamps, and what CCMS certification needs.
An Incoterms chart covering all 11 Incoterms 2020 rules by mode, carriage, insurance, and risk transfer point, plus how to pick the right one for a shipment.
Under DDP Incoterms 2020 the seller clears import and pays duty; under DAP the buyer does. Here is why that swap makes DDP risky for a non-resident seller.
CPT Incoterms have the seller pay carriage to a named destination while risk transfers to the buyer at origin. Here is exactly where that split happens.
FAS terms Incoterms and FOB both apply to sea freight only. See exactly where risk transfers under each, and why they differ from CPT and CIF.
