D
dletteri
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
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