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510(k), drop shipping, exports and exporting, germany, imports and importation, relabeling (of products), united states (usa)
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  #1  
Old 2nd August 2011, 01:40 PM
ISO tired ISO tired is offline
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Please Help! 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?

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Old 3rd August 2011, 01:58 AM
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Re: Importing Medical Devices into the USA from Germany (Drop Shipments)

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In Reply to Parent Post by ISO tired View Post

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?
Can someone help with this?

Thank you!!

Stijloor.
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Old 5th August 2011, 05:41 PM
sshankle sshankle is offline
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Re: Importing Medical Devices into the USA from Germany (Drop Shipments)

I believe this may be acceptable. I assume the German complany is registed as the manufacturer. Also, make sure your "Initial Importer" activities are squared away...

See: http://www.fda.gov/MedicalDevices/De.../ucm050126.htm
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