Premarket Approval (PMA) is the FDA’s regulatory pathway for high-risk Class III medical devices, which require extensive scientific evidence demonstrating safety and effectiveness before marketing in the United States. Unlike 510(k) or De Novo submissions, PMA applications often involve clinical study data and rigorous review processes.

At XPRO AMERICA, we provide end-to-end support for manufacturers seeking PMA approval, from clinical study planning to submission and post-market guidance, ensuring full compliance with FDA regulations.

Key Services:

• Clinical Study Support: We assist in designing, managing, and documenting clinical trials required to support PMA submissions, including Investigational Device Exemption (IDE) protocols if applicable.
• PMA Submission Preparation: XPRO AMERICA prepares the PMA dossier, incorporating device description, manufacturing information, preclinical and clinical study data, risk analysis, labeling, and instructions for use (IFU).
• eCopy & eSTAR Submissions: Our team converts PMA submissions into FDA-compliant eCopy or eSTAR formats, ensuring adherence to electronic submission requirements and smooth review processing.
• FDA Communication & Response Management: We liaise with FDA reviewers, respond to requests for additional information (AI), and facilitate clarifications to ensure efficient PMA evaluation.
• Post-Approval Guidance: After PMA approval, XPRO AMERICA assists with device listing, establishment registration updates, post-market reporting, and compliance with ongoing FDA requirements.

Why Choose XPRO AMERICA?

• Expertise in Class III medical device PMA submissions and regulatory strategy.
• Comprehensive support from clinical study design to FDA clearance.
• Proven experience managing FDA communications and submission formats.
• Minimizes regulatory risk and accelerates time-to-market for high-risk devices.

Partnering with XPRO AMERICA ensures that manufacturers of high-risk Class III devices confidently navigate the complex PMA pathway, achieve FDA approval, and maintain regulatory compliance throughout the product lifecycle. Our services streamline submissions, manage clinical data effectively, and provide strategic guidance for successful market entry.

XPRO AMERICA supports Class III medical devices with PMA submissions, clinical data preparation, eCopy/eSTAR submissions, and FDA communication.