This episode demystifies the distinct and critical roles of the FDA U.S. Agent and the Initial Importer for medical device manufacturers entering the U.S. market. We explore the specific regulatory responsibilities of each, highlighting why appointing a distributor without proven compliance expertise can jeopardize your import success and post-market standing. • What is the fundamental difference between an FDA U.S. Agent and an Initial Importer? • Who is legally responsible for reporting adverse device events to the FDA? • Can your distributor also act as your Initial Importer? • What are the risks of choosing an Initial Importer without proven regulatory processes? • Which entity is responsible for verifying a device's 510(k) or PMA status upon import? • How do these roles directly impact whether your shipments clear U.S. customs? • What specific post-market surveillance duties does an Initial Importer have? • Why is this distinction crucial for maintaining compliance once your device is in the U.S. market? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.