CDRH Industry: FDA’s Early Feasibility Studies Increase the Efficiency of Device Development

Today, the FDA’s Center for Devices and Radiological Health (CDRH) added a new section on the “Early Feasibility Studies Program,” to the Investigation Device Exemption (IDE)  webpage in Device Advice. The Early Feasibility Studies Program provides new opportunities to address unmet clinical needs and gain early clinical experience with innovative technology.  This new website provides information about conducting an early feasibility study for medical device developers.

An early feasibility study (EFS) is a limited clinical investigation of a device early in device development.  It typically:

• enrolls a small number of subjects;
• is used to evaluate the device design concept with respect to initial clinical safety and device functionality; and
• may guide device modifications.

The EFS program provides a mechanism for innovators, sponsors, FDA review teams, and clinicians to work together to develop novel technologies for patients in a timely manner.  The program represents a critical component of CDRH’s larger efforts to streamline the clinical trial initiative, to increase access for patients in the U.S. to potentially beneficial technologies and to support device innovation.

For more information about the EFS program, visit the new webpage or contact CDRH_EFS@fda.hhs.gov.

FDA’s Center for Devices and Radiological Health