For many medical devices, bench testing, biocompatibility studies, and performance data may be sufficient to demonstrate safety and effectiveness. However, in certain cases, the FDA requires clinical evidence to support a device’s regulatory submission. Knowing when clinical data is expected and preparing it correctly can be the difference between a smooth clearance and significant delays.

At XPRO AMERICA, we provide end-to-end clinical data support for manufacturers navigating the FDA review process. Our team helps determine whether clinical data is required, designs robust study protocols, and ensures proper submission formatting to meet FDA standards.

When is Clinical Data Required?
The FDA typically requests clinical data when:

• No suitable predicate device exists for a 510(k).
• The device has novel technology or mechanisms of action.
• Safety/effectiveness cannot be fully demonstrated through bench or animal studies.
• The device carries significant patient risk (Class III or select Class II devices).

Our Clinical Data Support Services:

• Regulatory Assessment: Guidance on whether clinical evidence is required, saving manufacturers from unnecessary costs and delays.
• Protocol Development: Designing clinical protocols aligned with FDA expectations, ensuring patient safety and meaningful data collection. If needed, we assist with Investigational Device Exemption (IDE) applications to legally conduct U.S. clinical trials.
• Study Management Support: Assistance with site selection, investigator guidance, informed consent requirements, and monitoring to ensure compliance with Good Clinical Practice (GCP).
• Data Compilation for Submission: Organizing and formatting clinical results into FDA-accepted formats, ready for inclusion in 510(k), PMA, or De Novo applications.

Why XPRO AMERICA?

• Expertise in both pre-clinical and clinical regulatory requirements.
• Strong understanding of FDA’s evolving expectations for novel devices.
• End-to-end support—from protocol design to FDA communication.
• Streamlined process to minimize trial delays and regulatory risk.

Whether you are submitting a 510(k) with clinical data, an IDE application, or a PMA requiring pivotal trial evidence, XPRO AMERICA provides the expertise to build a compelling, compliant submission. With our support, manufacturers can demonstrate safety and effectiveness while accelerating FDA approval timelines.

XPRO AMERICA provides FDA clinical data support, IDE protocol design, and submission guidance for device approvals requiring clinical evidence.