Private Label Distribution - US

dr1vn

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#1
I'm wondering if this is a gap:

Company A is a foreign manufacturer of a medical device with a 510(k). Company A wants to sell a private label version of the device to domestic Company B. Company A will label the box to the Company B's specifications including on the label "Distributed by Company B". A 3PL company in the US acts as initial importer and lists with the FDA. The 3PL in turn distributes the private label device to Company B who is not required to register or list with the FDA.

How does FDA/consumers ensure Company B is compliant to the QSR? Is Company A obligated to audit Company B?

I'm just worried as I feel there is no oversight on Company B.
 
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#2
If the private label company is solely a domestic distributor (no importing/exporting, no manufacturing), they are not required to register with the FDA. The liability would fall on whoever imports the device. It is their responsibility to ensure the device is compliant with all necessary standards and regulations, to my knowledge.

The FDA seems not to worry so much about the "middle-man", but rather the actual manufacturer and importer/exporter.

edit: Foreign manufacturers of medical devices imported into the US are required to register with the FDA.
 
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