I saw your posting and I'm afraid you're mistaken. You don't need a CFG if you export under §801(e)(1). You need to create a 801(e)(1) record for each country. The POs and matching packing lists should be stored with each order in the Export Record alon with the country certificate.
Remember that the device is labeled "for export only."
We routinely do this with our devices, all of which are Class III.
Good luck.
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SKIP RIMER
La Mesa CA
United States
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Original Message:
Sent: 27-Apr-2018 13:05
From: Kelly Foley
Subject: Export Certificates for Unapproved Medical Devices
Does anyone have experience with requesting export certificates from the FDA for an unapproved Class III medical device? I've determined that I need to request permits under 801(e)(2) because its a Class III device (801(e)(1) doesn't apply to class III devices) and doesn't comply with performance standards (802). Under 801(e)(2), we need a letter from the foreign liaison stating that the importing country approves. However, I've reached out to the foreign liaison listed on CDRH's website and they've returned the information multiple times unopened. Any guidance would be appreciated.
Thanks!
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Kelly Foley
United States
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