Shipping Medical Devices to US before pre market clearance

[Chef100]

Hi
I have question concerning shipping Medical Devices to US before pre market clearance.
Is it legal to ship finished Medical Devices from countries outside US to a warehouse in US while the 510k or special 510k application is still ongoing?

 

[Al Rosen]

Hi
I have question concerning shipping Medical Devices to US before pre market clearance.
Is it legal to ship finished Medical Devices from countries outside US to a warehouse in US while the 510k or special 510k application is still ongoing?

No it is not legal.
Look at Importing into the U.S. and meeting U.S, regulations for the answer:

Import Process

All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry.