Hello,
Does anyone have experience or some evidence of FDA's stance on distributing to US Embassies in other countries without following the regulatory pathway to distribute to the country in which the US Embassy is located?
Hypothetical example, let's say I have a Class 2 Med device that is NOT CE-marked and I want to distribute it to the US Embassy in France and other EU countries. Anyone know of any allowances here?
Thanks
Does anyone have experience or some evidence of FDA's stance on distributing to US Embassies in other countries without following the regulatory pathway to distribute to the country in which the US Embassy is located?
Hypothetical example, let's say I have a Class 2 Med device that is NOT CE-marked and I want to distribute it to the US Embassy in France and other EU countries. Anyone know of any allowances here?
Thanks