12 December 2017 - Ten years ago, when medical device manufacturers wanted to gain early clinical experience with their new devices they often went overseas to conduct first-in-human or small clinical studies.
Moving a device from bench to bedside for use in patients is a critical step along the development path. However, going overseas delayed access to potentially beneficial devices for American physicians and patients.
Today, FDA’s Center for Devices and Radiological Health (CDRH) has an Early Feasibility Studies Program that provides a route for innovators, sponsors, FDA review teams, and clinicians to work together to facilitate the early clinical evaluation of medical devices in the United States under the investigational device exemption regulations.