Foreign suppliers must first register with the United States Food and Drug Administration (FDA). Also, there is a listing requirement for medical devices and drug products.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.m.itbhdg.com/compliance/