Importing Medical Devices into the USA from Germany (Drop Shipments)

I

ISO tired

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?
 
Stijloor

Stijloor

Leader
Super Moderator
ISO tired said:
We are a subsidiary of a German company and registered as a relabler with the FDA. The German company needs to occasionally drop ships product directly to a hospital for a specific patient operation and by-pass us. We normally handle/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?
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Can someone help with this?

Thank you!!

Stijloor.
 
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