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Foreign Manufacturer selling in the US - Postmarket Surveillance question

Z

zmimshen

#1
A foreign manufacturer obtained a 510(k) clearance but is not currently selling in the US.
If a PMS order is sent - is that manufacturer required to conduct the study?
To date they have not sold in the USA and were not planning to get into the market for at least 6 more months... does anyone have any insight on the subject?

Thanks!
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
If US FDA has requested / directed you to do something, it would be a very bad idea to not respond and do nothing. You don't want to have to work your way back from having been initially categorized as a troublemaker.

I'd think you'd want to contact FDA, explain your circumstances and plans, and ask how you should comply.

If you expect to enter the market soon, my guess is that they'll tell you to commence a post market surveillance program as soon as you begin distribution.
 
Z

zmimshen

#3
Believe me... we are not planning to ignore them... That really would be a bad idea.
We are actually trying to contact the relevant person for the last 3 days with no luck...
I was mostly wondering if they can request from the company to start the study even though we are not yet selling in the USA, which does not make sense to me... :)
Thanks for your response.
 
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