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IDENT12345
I need some guidance on the following scenario....
Company "A" is a foreign ISO approved company and manufacturers a class I device known as XXX. Company "A" is the product specification owner of XXX and is registered with the FDA as a class I device. Company "B" is located in the US and has asked company "A" to manufacture device XXX and label it with company "B" name and change the device name YYY. In addition, company "B" has requested the menu on the device be changed. Once product labeling is complete, company "A" will package the product and label the packaging with company "B" name. The product will be shipped to company B in the US and warehoused until distribution (w/in and outside US).
Question:
1.) Is company "B" considered a an initial importer, relabeler, or specification developer for device YYY?
Company "A" is a foreign ISO approved company and manufacturers a class I device known as XXX. Company "A" is the product specification owner of XXX and is registered with the FDA as a class I device. Company "B" is located in the US and has asked company "A" to manufacture device XXX and label it with company "B" name and change the device name YYY. In addition, company "B" has requested the menu on the device be changed. Once product labeling is complete, company "A" will package the product and label the packaging with company "B" name. The product will be shipped to company B in the US and warehoused until distribution (w/in and outside US).
Question:
1.) Is company "B" considered a an initial importer, relabeler, or specification developer for device YYY?