Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US

[UTskier1]

I am uncertain if I must register with the FDA as an initial importer. I will be distributing a medical device to the end user that is 100% manufactured and sterilized by a US based OEM and product will be delivered from the US facility to my US facility. No importing/customs requirements. The design file owner of the device is based in Ireland. The Irish company is listed with the FDA and will hold the 510k registrations. The labeling of the product will carry our logos, branding and barcodes. The label will list the Irish company as the manufacturer and my company as the distributor. I have not been able to find clear guidance for the situation.

 

[monoj mon]

I would suggest you to send an email to [email protected] with the above explanation.

Edited to add the following:
After thinking for a while, I have got some idea to address your situation. But, I would still suggest you to talk to the FDA directly.

Since, the Irish company does not physically manufacture anything rather than being the owner of 510(k), they could register/list as a 'Specification Developer'

And since the OEM in the US is manufacturing the device to the specification of the Irish company, they could register/list as a 'contract manufacturer.

I don't see the need of registering your facility as the 'Initial Importer' since you are not physically importing anything.

In the above definition the 'Manufacturer' means

Which is actually the OEM company, but since they are 'Manufacturing' the device with 'specification developed' by the Irish company, they are 'Contract Manufacturer'.

On your label you should be able to keep the same arrangement as you have mentioned.