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.