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Glossary Term
First-in-Human Trial
Definition
A First-in-Human (FIH) Trial is the initial phase of clinical testing in which a medical device, drug, or treatment is tested in human subjects for the first time. The primary objectives are to evaluate safety, feasibility, and preliminary device performance or therapeutic effects. FIH trials are a critical milestone in translating preclinical research into clinical practice.
Relevance to the MedTech Industry
FIH trials bridge the gap between preclinical development and broader clinical evaluation, providing essential data on safety and functionality in humans. They allow MedTech companies to refine device designs, assess biological interactions, and establish the groundwork for regulatory submissions and subsequent clinical trials.
Additional Information & Related Terms
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