The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States.

At XPRO AMERICA, we provide comprehensive support for manufacturers and importers to prepare, submit, and manage 510(k) premarket notifications, ensuring compliance with FDA regulations and accelerating device approval.

Key Services:

• Substantial Equivalence Evaluation: We compare your device to legally marketed predicate devices to determine substantial equivalence, ensuring the correct classification and submission pathway.
• 510(k) Submission Preparation: Our team prepares the 510(k) dossier, including device description, intended use, labeling, performance data, biocompatibility testing, and risk assessments in accordance with FDA guidance.
• FDA Interaction & Communication: XPRO AMERICA manages communications with FDA reviewers, responds to requests for additional information, and facilitates clarifications to support smooth and timely review.
• Technical & Documentation Support: We review design files, testing reports, labeling, and software documentation to ensure completeness, compliance, and readiness for FDA review.
• Post-Clearance Guidance: Once the FDA issues clearance, we assist with device listing, establishment registration updates, and post-market regulatory obligations to maintain ongoing compliance.

Why Choose XPRO AMERICA?

• Extensive experience preparing and submitting 510(k) notifications for Class II devices.
• Strategic guidance to reduce review cycles and regulatory risk.
• End-to-end support from dossier preparation to FDA clearance.
• Proven expertise in regulatory documentation, testing compliance, and reviewer liaison.

Partnering with XPRO AMERICA ensures that manufacturers and importers of Class II devices achieve timely 510(k) FDA clearance, maintain regulatory compliance, and streamline their pathway to market. Our services provide confidence, minimize risk, and ensure smooth FDA interactions throughout the premarket notification process.

XPRO AMERICA supports 510(k) submissions for Class II devices, demonstrating substantial equivalence and managing FDA interactions until clearance.