Z
zmimshen
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!
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!