Medical Device Importer, Distributor, or Manufacturer?

D

dletteri

#1
Hello all,

Here is my situation:

I am an FDA-registered medical device manufacturer. I have devices listed with the FDA, and have 510(k) approval to market those devices.

I am now going to buy an instrument from Germany. It will have the OEM's name (not my company's name) on the label, and I am going to resell it.

The question is, does this make me an importer, a distributor, or a manufacturer of the device in the eyes of the FDA? I have referenced 21 CFR 807.3, and also "Medical Device Tracking; Guidance for Industry and FDA Staff", and I can't decide which definition is appropriate.

Second question: to complicate matters, what if the label says "Manufactured by <OEM Company Name>", but also "Distributed by <My Company Name>"? How does that muddy the situation?

Thanks for any help.

Regards,

Dave
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello all,

Here is my situation:

I am an FDA-registered medical device manufacturer. I have devices listed with the FDA, and have 510(k) approval to market those devices.

I am now going to buy an instrument from Germany. It will have the OEM's name (not my company's name) on the label, and I am going to resell it.

The question is, does this make me an importer, a distributor, or a manufacturer of the device in the eyes of the FDA? I have referenced 21 CFR 807.3, and also "Medical Device Tracking; Guidance for Industry and FDA Staff", and I can't decide which definition is appropriate.

Second question: to complicate matters, what if the label says "Manufactured by <OEM Company Name>", but also "Distributed by <My Company Name>"? How does that muddy the situation?

Thanks for any help.

Regards,

Dave
Hi,

As long as you don't specify or modify the device, including its packaging, labelling and intended use (by way of promotion or representation), and your name is not on the product, you are classified as an importer / initial distributor rather than a manufacturer.

In the second scenario you described (all above conditions standing), it depends on the contract between you and the actual manufacturer, which better explicitly state who bears the regulatory responsibility.

Cheers,
Ronen.
 
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