April 23, 2024
By Ouided Rouabhi and Andrew Farb
Last October marked the 10-year anniversary of the Food and Drug Administration (FDA) Center for Devices and Radiological Health’s (CDRH) Early Feasibility Studies (EFS) Program and the publication of FDA’s Guidance on Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies (EFS Guidance). Since its inception, the program has supported device innovation and increased patient access to potentially beneficial new technologies. EFS allow investigators to gain early clinical experience with investigational devices, often to address unmet clinical needs, while incorporating enhanced risk mitigation strategies to protect patients. This early clinical experience provides initial insights into device proof-of-principle and safety, guides device and procedure improvements, and informs clinical study modifications and non-clinical testing strategies, which together enhance device development efficiency.
Important benefits of performing an EFS in the United States (US) include early and ongoing interactions with FDA staff that promote collaboration with device developers, industry sponsors, and clinical investigators. A successfully executed US EFS can streamline the transition to a pivotal trial and help accelerate progress towards marketing authorization. These benefits can be particularly valuable for new devices (or new uses of approved devices) that are intended for the US market.
Prior to the EFS Program launch in 2014, initial clinical testing of novel devices was often conducted overseas, delaying US patient access to beneficial new devices and US physician and clinical site experience with new products. To address this issue and as part of CDRH’s commitment to promoting public health by improving US patient access to new devices and strengthening the clinical trial enterprise, we considered the device development process holistically, starting at the earliest stage of clinical evaluation. The EFS Guidance provided a regulatory toolkit containing new recommendations and policies to help study sponsors communicate the information needed to move from bench to bedside under an approved EFS IDE. Over the years, we have promoted the EFS Program through direct outreach to sponsors and partnering with stakeholders like the Medical Device Innovation Consortium.
Figure. Early Feasibility Study Submissions and Approvals. The y-axis shows the number of EFS IDEs submitted (in blue) and those fully approved or approved with conditions in the first review cycle (i.e., within 30 calendar days) between fiscal years 2014 – 2023 on the x-axis. This data excludes submissions which were withdrawn by the sponsor, as well as any submissions which were determined not to require an IDE (e.g., nonsignificant risk studies).
EFS are currently being used across all CDRH device areas. Approximately 60 new EFS IDE submissions are reviewed each year and over 70% of EFS IDEs are approved by FDA within 30 calendar days (see Figure). Over 430 EFS IDEs have been approved since the launch of the program and have included over 4000 study participants. As we move into this next decade of EFS, CDRH looks forward to supporting the program growth, working collaboratively with sponsors, investigators, and patient advocates to increase the number of EFS IDEs. We encourage device innovators and manufacturers to consider using the EFS Program to evaluate novel products and contact CDRH to learn more. Please contact us (ouided.rouabhi@fda.hhs.gov and andrew.farb@fda.hhs.gov) for more information about the EFS Program.
Additional resources can be found on the EFS Program webpage.
