Shipment of a CE Approved Class III Device to the EU Member States

#1
I am hoping that a subject matter expert can provide some advice. I am with a medical device start-up company in Irvine that recently received CE approval for 2 products, both Class III. We are registered with the FDA as an exporter. I was advised that I would also need to obtain a Certificate of Exportability from the FDA. After going through the application process, the FDA rejected the request citing the fact that we have not had an FDA inspection. We are a few years away from USFDA approval and the need for an FDA site inspection. I would appreciate the advice from anyone that may have had a similar experience and what the workaround was. Your advice is very much appreciated.

Best Regards,
Steve P
 
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