An Investigational Device Exemption (IDE) allows medical device manufacturers to conduct clinical trials in the United States using investigational devices that have not yet received FDA clearance or approval. IDE submissions enable the collection of safety and effectiveness data essential for regulatory pathways such as 510(k), De Novo, or PMA.

At XPRO AMERICA, we offer expert guidance and full-service support for companies navigating the IDE process, ensuring compliance with FDA regulations while facilitating clinical research.

Key Services:

• IDE Eligibility Assessment: We evaluate your device and intended study to determine whether an IDE is required, and identify the appropriate regulatory pathway for clinical investigation.
• IDE Submission Preparation: Our team prepares comprehensive IDE applications, including device description, clinical protocol, risk analysis, labeling, informed consent templates, and supporting preclinical data.
• FDA Communication & Review Support: XPRO AMERICA manages communications with FDA reviewers, addresses requests for additional information, and facilitates clarifications to ensure timely IDE approval.
• Clinical Trial Planning & Management: We assist in designing study protocols, selecting investigators, monitoring regulatory compliance, and coordinating submission updates to FDA during the trial.
• Post-IDE Guidance: Following IDE approval, we provide support for amendments, annual reports, safety reporting, and transition to post-market regulatory submissions if needed.

Why Choose XPRO AMERICA?

• Expertise in IDE preparation, submission, and FDA review navigation.
• Strategic guidance to ensure clinical trial compliance and efficiency.
• End-to-end support from eligibility assessment to post-IDE reporting.
• Minimizes regulatory risk while accelerating data collection for device approval.

Partnering with XPRO AMERICA ensures that medical device manufacturers and clinical research teams can confidently conduct investigational trials in the U.S., meeting all FDA requirements while generating robust clinical evidence to support future regulatory submissions.

XPRO AMERICA provides IDE guidance for U.S. clinical trials, including FDA submission support, regulatory compliance, and trial management for devices.