For medical device manufacturers and importers, compliance with the U.S. Food & Drug Administration (FDA) is not optional—it’s a legal requirement. Every year, companies must complete FDA Establishment Registration and Device Listing to maintain access to the U.S. market. While the process may seem complex, XPRO America makes it simple, efficient, and stress-free.

What is FDA Establishment Registration?
FDA Establishment Registration is the process by which manufacturers, contract manufacturers, repackagers, relabelers, and importers notify the FDA of their facilities. This registration provides transparency and accountability, ensuring the FDA knows exactly where medical devices are produced, tested, or distributed.

Why Annual Renewal is Required
FDA registration is not a one-time event—it must be renewed each year between October 1 and December 31. Companies that miss renewal deadlines risk being removed from the FDA database, which can lead to shipment holds, customs delays, or product bans in the U.S. market.

What is Device Listing?
Along with registering your facility, you must also provide detailed information about the medical devices you manufacture or distribute. Device listing helps the FDA monitor safety, recall processes, and regulatory compliance. Each device must be accurately classified and linked to its intended use.

Common Challenges Businesses Face

• Complex FDA terminology and guidelines
• Errors in device classification or listing
• Missing annual renewal deadlines
• Difficulty coordinating across global teams

How XPRO America Makes it Easy
At XPRO America, our experts provide end-to-end support for FDA Establishment Registration and Device Listing. We assist with:

• Annual Registration Renewal – Never miss the critical deadlines
• Device Classification Support – Accurate and compliant listing of your devices
• Regulatory Guidance – Avoid costly errors and non-compliance risks
• Communication with FDA – Acting as your U.S. representative for smooth operations

Benefits of Partnering with XPRO America

• Peace of mind knowing your FDA status is always current
• Faster U.S. market entry for new devices
• Reduced risk of customs issues or product holds
• Professional compliance support tailored to your industry

Conclusion
The U.S. medical device market offers enormous opportunities, but only for businesses that remain FDA-compliant. Annual FDA Establishment Registration & Device Listing is a critical step. With XPRO America as your trusted partner, you can focus on innovation and growth while we handle the regulatory details.