After successfully navigating the 510(k) or De Novo submission process, medical device manufacturers must secure their FDA clearance certificate and ensure ongoing compliance with post-market requirements. Timely clearance and accurate post-market setup are essential for legal distribution and long-term regulatory success in the U.S. market.

At XPRO AMERICA, we provide end-to-end support for FDA clearance and post-market setup, helping device companies transition smoothly from premarket approval to market launch and ongoing compliance.

Key Services:

• Obtaining FDA Clearance Letter: Once the FDA completes the review process and confirms that a device is substantially equivalent or meets De Novo criteria, a formal clearance letter is issued. XPRO AMERICA manages communications and documentation to ensure receipt of this critical regulatory milestone.
• Device Listing & Establishment Registration Updates: Following clearance, devices must be accurately listed in the FDA database, and establishments must maintain current registration information. Our team ensures that all device listings and facility registrations comply with FDA regulations and are updated in a timely manner.
• Post-Market Reporting Guidance: FDA mandates ongoing monitoring and reporting for medical devices, including Medical Device Reporting (MDR) for adverse events. XPRO AMERICA provides comprehensive guidance on post-market reporting obligations, ensuring your organization meets compliance requirements while minimizing risk.
• Regulatory Compliance Support: Beyond clearance, we advise on labeling updates, modifications to devices, and post-market surveillance strategies. This proactive approach helps companies avoid enforcement actions, recalls, or import alerts.

Why Choose XPRO AMERICA?

• Expert guidance from premarket submission to post-market compliance.
• Streamlined processes for receiving FDA clearance letters and device listings.
• Risk mitigation strategies to meet FDA MDR and reporting requirements.
• Tailored solutions for medical device manufacturers and exporters.

By partnering with XPRO AMERICA, companies gain confidence that their devices are not only cleared for U.S. market entry but also fully compliant with post-market regulatory obligations. This ensures uninterrupted market access, adherence to FDA expectations, and protection of patient safety.

XPRO AMERICA secures FDA clearance letters, updates device listings, and provides guidance on post-market reporting and MDR compliance.