Successful FDA 510(k) submissions require not only a complete dossier but also effective communication with the FDA throughout the review process. Misunderstandings, incomplete responses, or delays in addressing Additional Information (AI) requests can prolong approval timelines and create regulatory risk.

At XPRO AMERICA, we provide end-to-end support for FDA communication and response handling, ensuring your submission progresses smoothly and efficiently.

Key Services:

• 510(k) Submission via FDA CDRH: We prepare and submit your 510(k) application electronically through the FDA’s Center for Devices and Radiological Health (CDRH) portal, ensuring compliance with formatting, technical, and administrative requirements.
• Responding to FDA AI Requests: The FDA often issues requests for Additional Information (AI) when further clarification, testing data, or labeling information is needed. XPRO AMERICA manages these responses professionally, providing clear, concise, and compliant answers to reduce review cycles.
• Liaison with FDA Reviewers: Maintaining proactive communication with FDA reviewers is critical. Our experts act as your liaison, facilitating discussions, clarifying technical questions, and ensuring that your submission remains on track.

Why Effective FDA Communication Matters:

• Prevents delays due to incomplete or misunderstood submissions.
• Reduces the risk of Refuse-to-Accept (RTA) letters or extended review cycles.
• Builds a professional and collaborative relationship with FDA reviewers.
• Ensures that critical regulatory requirements are addressed accurately and promptly.

Benefits of Partnering with XPRO AMERICA:

• Experienced in handling FDA communication for 510(k), De Novo, and other device submissions.
• Streamlined process to address AI requests efficiently, saving time and resources.
• Expert guidance on strategy, content, and timing for optimal submission outcomes.
• Enhanced confidence that your medical device submission is fully compliant and ready for clearance.

With XPRO AMERICA, manufacturers and exporters can focus on product development and market strategy while we manage the complexity of FDA communications, AI responses, and reviewer liaison. Our goal is to facilitate smooth device approval and reduce regulatory obstacles, enabling faster access to the U.S. market.

XPRO AMERICA manages FDA communications, AI responses, and liaises with reviewers for smooth 510(k) submission and faster device clearance.