Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
Everything U.S. MedTech, biopharma, and radiopharma sponsors need to know about running a first-in-human (FIH) or early feasibility (EFS) study — and how bioaccess® anchors on U.S. regulatory strategy while executing across Latin America.
A first-in-human (FIH) clinical trial is the first administration of a new investigational medical device, drug, or biological product in human subjects. FIH studies are small, closely monitored, and designed to gather preliminary safety and performance data before larger clinical studies.
An EFS is a limited clinical investigation of a device early in development — often before the device design is finalized — to evaluate design concepts with respect to initial clinical safety and functionality. A device FIH is frequently structured as an EFS.
U.S. sponsors run FIH studies in Latin America to compress ethics and regulatory startup timelines, access large treatment-naïve patient populations, and lower per-patient site cost — while generating ICH-GCP-quality data that supports U.S. submissions under 21 CFR 812.28.
Data from a FIH study conducted outside the United States may support an IDE, 510(k), De Novo, or PMA under 21 CFR 812.28 when the study was conducted to Good Clinical Practice (ICH E6) and ISO 14155, and the FDA is able to validate the data. Alignment via an FDA Pre-Submission before enrollment is strongly recommended.
Evaluate physician-led clinical leadership, direct FIH/EFS device experience, a documented U.S. regulatory strategy (FDA Pre-Sub / IDE / IND), ICH-GCP quality systems, and in-country regulatory relationships.