Proper device classification and regulatory pathway determination are essential first steps for marketing medical devices in the United States. The FDA classifies devices as Class I, II, or III, based on risk level, intended use, and regulatory controls. Choosing the correct submission route 510(k), De Novo, or PMA (Premarket Approval)—is critical to ensure compliance and accelerate market entry.

At XPRO AMERICA, we provide expert guidance for medical device manufacturers and importers to navigate FDA classification rules and determine the optimal regulatory pathway.

Key Services:

• Device Classification (Class I, II, III): We assess your device based on intended use, technological characteristics, and predicate devices to determine its FDA classification. Accurate classification ensures compliance with the appropriate controls and reduces regulatory risk.
• Submission Route Determination: Based on device classification and novelty, we advise on the proper FDA submission pathway:
  • 510(k) Clearance: For devices substantially equivalent to legally marketed predicate devices.
  • De Novo Classification: For novel low- to moderate-risk devices without a predicate.
  • PMA (Premarket Approval): For high-risk Class III devices requiring extensive clinical and technical data.
• Regulatory Strategy & Planning: XPRO AMERICA develops a regulatory roadmap, outlining submission timelines, required documentation, and strategic recommendations to achieve FDA clearance efficiently.
• Supporting Documentation & Gap Analysis: We review technical files, performance data, and labeling to ensure compliance and readiness for FDA review.
• FDA Communication & Submission Support: Our team assists in preparing the submission, liaising with FDA reviewers, and responding to requests for additional information to facilitate smooth regulatory approval.

Why Choose XPRO AMERICA?

• Expertise in medical device classification, 510(k), De Novo, and PMA pathways.
• Strategic guidance to minimize delays and regulatory risk.
• End-to-end support from initial assessment to FDA submission and approval.
• Proven track record in navigating complex FDA regulations for domestic and foreign manufacturers.

Partnering with XPRO AMERICA ensures that medical device companies accurately determine device classification and submission pathways, maintain regulatory compliance, and achieve timely market access. Our comprehensive services streamline FDA interactions and provide confidence throughout the product approval process.

XPRO AMERICA guides medical device companies in FDA device classification and selecting the correct regulatory submission pathway: 510(k), De Novo, or PMA.