New Program

Historically, feasibility studies often have been conducted Outside of the United States due to real or perceived resource constraints/ requirements (costs and time) associated with performing studies domestically. When medical technology developers prioritize conducting feasibility and pivotal clinical studies outside of the United States, the relevant technologies are delayed in reaching US patients, and delayed in providing clinicians with hands-on experience using the technology. The FDA’s Center for Devices and Radiological Health (CDRH) established its EFS program in an effort towards achieving its strategic priority of facilitating First-in-World patient access to safe and effective new technologies of significant health importance. Recognizing that support during the earliest phases of medical device testing encourages innovation and access for U.S. patients, MDIC supports this strategic priority through various working groups within MDIC’s Early Feasibility Study (EFS) initiative.