The De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain FDA marketing authorization by demonstrating safety and effectiveness while establishing a new device classification.

At XPRO AMERICA, we provide expert guidance and full-service support for companies pursuing De Novo classification, ensuring a strategic and compliant approach to FDA submissions.

Key Services:

• Device Assessment & Regulatory Strategy: We evaluate your device to determine eligibility for De Novo classification and develop a regulatory roadmap, outlining submission strategy, timelines, and required documentation.
• Submission Preparation: XPRO AMERICA assists in preparing comprehensive De Novo requests, including device description, intended use, risk analysis, performance testing, labeling, and supporting scientific evidence in line with FDA expectations.
• FDA Communication & Liaison: We manage communications with FDA reviewers, address requests for additional information, and facilitate clarifications to ensure a smooth and timely review process.
• Documentation Review & Compliance: Our team ensures that all technical files, labeling, and performance data are complete, accurate, and compliant with applicable regulations, reducing the risk of delays or deficiencies.
• Post-Classification Support: After FDA grants De Novo clearance, we assist with device listing, establishment registration updates, and guidance on post-market regulatory obligations to maintain ongoing compliance.

Why Choose XPRO AMERICA?

• Expertise in novel device regulatory strategy and De Novo submissions.
• End-to-end support from initial assessment to FDA clearance.
• Proven experience liaising with FDA reviewers for efficient review outcomes.
• Reduces regulatory risk and ensures timely market access for innovative devices.

Partnering with XPRO AMERICA ensures that manufacturers of novel medical devices can confidently navigate the De Novo classification process, achieve FDA clearance, and maintain compliance throughout the product lifecycle. Our services streamline submissions, minimize delays, and provide strategic regulatory guidance for successful market entry.

XPRO AMERICA assists with De Novo classification for novel devices, providing regulatory strategy, FDA communication, and submission support.