OBJECTIVES: Medical device development often involves iterative design modifications during pre-clinical and early clinical evaluations. Early Feasibility Studies (EFS) are limited clinical investigations, aimed at evaluating design concepts concerning initial clinical safety and functionality, potentially informing design modifications. These studies are the focus of a dedicated FDA program in the US and classified under EN ISO14155:2020 in Europe. Despite their importance, no public registries exist of EFS and there is limited evidence on their recent use and impact. This study aimed to identify and describe EFS conducted for medical devices globally.

METHODS: We extracted information from several public clinical study registries and previous systematic literature reviews. We included all studies defined as EFS as well as all interventional, open-label studies with a sample size <30 patients (EFS-like). For each study, data collected included sample size, therapeutic area, primary and secondary outcomes, sponsors and investigating centers, study status, and related publications. Information was retrieved from the registries using a web scraping algorithm when needed. Data was analyzed using descriptive statistics.

RESULTS: Overall, the dataset comprises 559 EFS and EFS-like studies, predominantly located in the United States (about 45% of the sample), followed by European countries (28%). Nearly half of the studies focus on circulatory system diseases, while around 10% of them remain incomplete (suspended, terminated, withdrawn or withheld). Notably, the number of conducted studies has shown a stable increasing trend in recent years, both in Europe and in the US.

CONCLUSIONS: EFS studies have been increasingly used during medical device development in the US and Europe. However, their impact on approval time, and post-market safety and efficacy profiles is still unclear. Reporting standards for EFS in publicly available registries would improve transparency and facilitate research on their role for device development.