Dear all!
Imagine the follwing situation.
A patient from US travels from US to Europe for getting treated with an active implantable device system, which has no market approval in the US, only in Europe.
After the implantation the patient travels home to US again...
How can a distributor send spare parts to this patient (which he might need for the external system components of the device)?
Respectively - is this allowed?
Would there be any troubles at the US customs or with FDA?
Thanks in advance!
BR
Aphel
Imagine the follwing situation.
A patient from US travels from US to Europe for getting treated with an active implantable device system, which has no market approval in the US, only in Europe.
After the implantation the patient travels home to US again...
How can a distributor send spare parts to this patient (which he might need for the external system components of the device)?
Respectively - is this allowed?
Would there be any troubles at the US customs or with FDA?
Thanks in advance!
BR
Aphel