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How to Register a Medical Device with the US FDA

How to Register a Medical Device with the US FDA

This video walks you through the complete FDA registration process for medical devices in the United States, from classification and documentation to appointing a US Agent and submitting your application. Learn how to navigate the world’s largest medtech market, where over 40% of global device sales take place, and where FDA clearance sets the global standard. Whether you’re a first-time entrant or expanding your US presence, this guide helps you avoid costly delays and launch with confidence.

Published on:
July 28, 2025

This video provides a clear, step-by-step overview of how to register a medical device with the US Food and Drug Administration (FDA), the world’s most influential health regulatory authority. From determining your device classification to appointing a US Agent, preparing documentation, and submitting your application, this guide demystifies the entire US registration pathway so you can bring your technology to the largest medtech market on the planet.

Topics covered in this video include:

  • US medical device market dynamics and growth trends
  • The FDA’s risk-based device classification system
  • The role and responsibilities of a US Agent
  • Documentation, submission requirements, and eSTAR dossiers
  • Quality Management System expectations under 21 CFR 820/QMSR
  • How Pure Global accelerates your FDA clearance

The United States remains the top destination for medical device innovators. With nearly 340 million residents and accounting for over 40% of global medtech sales, it is projected to hit US $199 billion by 2025, with the IVD segment alone reaching $41.4 billion. Aging demographics, rising chronic-disease burdens, and aggressive R&D investment fuel steady growth, while FDA clearance or approval stands as the gold standard for credibility in markets worldwide. Entering this market requires not only technical excellence but also a deep understanding of how to navigate FDA’s complex regulatory landscape.

In the US, all medical devices and IVDs are classified based on risk (Class I, II, or III), which determines your registration pathway—whether 510(k), De Novo, or PMA. Compliance also requires implementing a Quality Management System that meets FDA’s Quality System Regulation (21 CFR Part 820) and the upcoming Quality Management System Regulation (QMSR). Appointing a US Agent is mandatory for all foreign manufacturers to maintain direct contact with the FDA’s Center for Devices and Radiological Health (CDRH).

Need help registering with the FDA?
Pure Global’s global team is made up of former FDA reviewers, regulatory strategists, and clinical affairs experts. We guide medical device manufacturers through every stage of the registration process. From determining your classification and pathway to preparing and submitting 510(k), De Novo, or PMA dossiers, acting as your US Agent, and managing post-market compliance, we simplify the path to the US market so you can focus on innovation. Contact us to learn more about FDA US Medical Device Registration.

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