This document provides essential guidance for manufacturers on the minimum requirements for lifecycle management of in vitro diagnostic (IVD) medical devices developed for public health emergencies involving infectious agents. It outlines key considerations for ensuring the immediate availability and regulatory authorization of emergency use IVDs.

While this document does not replace existing national or regional regulatory requirements for IVDs in non-emergency situations, it highlights critical aspects of risk management, post-market performance monitoring, quality assurance, and communication systems that must be implemented for emergency-use IVDs.