US Initial Importer vs. Distributor

[RA_QA_Expert]

Hello, please help with FDA definitions

if EU based Specification Developer cooperates with US based Contract Manufacturer and have US based sales entity, is that US entity Initial Importer or Domestic Distributor?

in other words, EU Spec.Dev. is "Foreign Manufacturer", US Con.Man. physically produces a devices, these devices are transported directly to US sales entity and sold only in USA (it will not cross US border), but these devices will bear Foreign Manufacturer address.

Based on FDA Initial Importer - Any importer who furthers the marketing of a device from a foreign manufacturer... the sales entity should be Initial Importer even the devices are produced and sold in USA. Or?

Thank you for any advice

 

[Ed Panek]

The company is EU has the FDA clearance for the device and is on the submission paperwork?

 

[RA_QA_Expert]

The company is EU has the FDA clearance for the device and is on the submission paperwork?

Yes, EU company is registered as specification developer. US production company as contract manufacturer. Both companies must include this product to FDA database, the product is 510(k) etc. exempt and only "FDA listing" is needed.

EU company will be refered on product label (spec.dev. = legal manufacturer), but with "Made in USA".

Thus are these products considered as imported devices even physically will not cross US border?
Thank you

 

[Ed Panek]

U.S. Agents

The rules and responsibilities of a U.S. agent in relation to medical device imports.

www.fda.gov

I am uncertain as to the answer here however I am certain your freight forwarder would know. Fed Ex, UPS, Etc