New FDA Import Codes "Affirmations of Compliance"

G

GPjeri

#1
FDA issued a letter to industry March 24, 2011 regarding use of AoC's to ease import [ Import Entry Review Process] of med devices (including IVD's). Our business is IVD, and try as I might I can not find AoC's for our assays (NAT) , technology, or instrument systems. I've tried using their feedback area, checked out the tutorial site as well, and emailed CDRH Office of Compliance but have yet to receive a reply. Does anyone know of a 'better way/place' to find these codes? I'm asking because recently we had a very simple class I instrument held up at port of entry due to lack of a code but there isn't one, so we made a best guess.

Thanks in advance for your replies :rolleyes:
 
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S

samsung

#2
Re: New Import Codes "Affirmations of Compliance"

FDA issued a letter to industry March 24, 2011 regarding use of AoC's to ease import [ Import Entry Review Process] of med devices (including IVD's). Our business is IVD, and try as I might I can not find AoC's for our assays (NAT) , technology, or instrument systems. I've tried using their feedback area, checked out the tutorial site as well, and emailed CDRH Office of Compliance but have yet to receive a reply. Does anyone know of a 'better way/place' to find these codes? I'm asking because recently we had a very simple class I instrument held up at port of entry due to lack of a code but there isn't one, so we made a best guess.

Thanks in advance for your replies :rolleyes:
A google search brought these results. Can't say if it's what you are looking for.
 
M

MIREGMGR

#4
If you haven't yet, you should call DSMICA and ask them to direct you to whoever can get you an answer.
 
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