FDA Measures for Early Feasibility Studies for Devices Bears Fruit

Over the last few years, FDA created the Early Feasibility Studies (EFS) program to encourage developers of new medical devices to conduct such studies in the US under IDEs instead of other countries. An EFS is a small clinical trial on an early prototype of a Class III medical device to evaluate the design concept, safety and functionality which would lead to the final configuration of the device for the pivotal clinical trial. Under the EFS program, FDA provides increased interactions with the developers to design better trials and address critical safety and feasibility issues, faster approval of the IDE under the EFS program, and flexibility in regulatory requirements to allow trials with early prototypes. FDA approved 75% of the IDE submissions under this program within 30 days of submission. According to FDA, about half of the companies who benefited from the EFS program were small companies. The EFS program is beneficial to all developers but particularly to small developers with limited resources who may find doing early stage development in other countries more challenging but much easier in the US, thanks to a highly collaborative and interactive FDA.