Pilot Studies, Feasibility Studies, and Clinical Investigations

A “pilot,” “feasibility study,” or “limited evaluation” is not a regulatory classification. These labels may describe the size, maturity or commercial scope of an activity, but they do not determine whether it is a clinical investigation, whether the device is investigational, or whether Food and Drug Administration or Institutional Review Board approval is required.

Classify the Activity From Its Actual Protocol and Conduct

FDA defines an investigation as clinical research involving one or more human subjects to determine the safety or effectiveness of a device. An early feasibility study is generally a small, early-stage clinical investigation used to evaluate initial clinical safety, device functionality or a design concept and may guide later device modifications.

Depending on the device, intended use, procedures and risks, a feasibility or pilot study may be exempt from Investigational Device Exemption requirements, may proceed as a nonsignificant-risk study under IRB oversight, or may require an FDA-approved IDE as a significant-risk study.

The sponsor should therefore classify the activity from its actual protocol and conduct, not from its working title.

A Commercial Pilot Has a Different Purpose

A commercial pilot is usually a limited commercial deployment intended to test matters such as ordering, fulfillment, training, installation, adoption, customer support, pricing, reimbursement workflows or channel performance.

When a legally marketed device is used within its cleared or approved indications and ordinary clinical practice, gathering operational, service or commercial information does not necessarily turn the activity into an IDE study. FDA regulations also recognize limited testing that is not intended to determine safety or effectiveness and does not place subjects at risk.

A Commercial Pilot Can Become a Clinical Investigation

The distinction can erode quickly. A commercial pilot may become a clinical investigation when participants are prospectively assigned device use under a protocol, the device or its use differs from the cleared or approved configuration or indications, additional clinical procedures are imposed, or data are collected systematically to determine safety or effectiveness.

Calling the activity a market test, evaluation, beta program or limited launch does not change that analysis. Investigational devices also may not be promoted or test-marketed before authorization for commercial distribution.

Focus on Why the Device Is Being Used

Both commercial pilots and clinical pilot studies can generate useful evidence. The controlling questions are why the device is being used, what data are being collected, what is being done to human subjects, whether the activity changes ordinary care, and how the resulting evidence will be used.

Those decisions should be documented before devices are shipped, sites are activated or commercial communications begin.

Coordinate Distribution After the Regulatory Pathway Is Confirmed

Through MDD Studies, MDD Options can coordinate importation and controlled U.S. distribution after the appropriate IDE or IRB documentation is available.

The model supports study intake, inventory controls, site shipments, temperature-controlled distribution, returns, reconciliation and device-accountability records. MDD Options can also assemble the information needed for specialist review where the correct IDE pathway remains uncertain.