Importing Medical Devices into the USA from Germany (Drop Shipments)
We are a subsidiary of a German company and registered as a relabler with the FDA. The German company needs to ocassionaly drop ships product directly to a hospital for a specific patient operation and by-pass us. We normally hanlded/distribute all product within the USA. The RA director is also their US agent. There is a 510k cleance on this product.
The question is does this violate any FDA regulations by us not re-labeling or inspecting the product?