Abstract 

The process of emergency use authorisation (EUA) was adopted by the US Food and Drug Administration (FDA) to accelerate the deployment of in vitro diagnostic (IVD) devices during public health emergencies. Initially developed in 2004 as a response to bioterrorism threats, the EUA framework has become a critical regulatory mechanism, particularly highlighted during the COVID‑19 pandemic, to expedite access to diagnostic tools and therapeutic interventions.

This article explores the FDA’s EUA framework, focusing on its evolution, operational mechanisms and significance in public health preparedness. It also examines eligibility requirements, the post‑authorisation responsibilities of stakeholders, and the potential impact of emerging technologies such as artificial intelligence (AI) on IVD regulation.