This document establishes requirements for the quality, safety, performance, and documentation of laboratory-developed tests (LDTs) based on their intended use in the diagnosis, prognosis, monitoring, prevention, or treatment of medical conditions. It outlines the principles and assessment criteria for designing, developing, validating (both analytically and clinically), manufacturing, and monitoring LDTs for internal use by medical laboratories.

The scope of this document includes regulatory-approved in vitro diagnostic (IVD) medical devices used outside their approved labeling or instructions, such as different sample types, instruments, or reagents. While this document follows best practices and state-of-the-art approaches, it does not provide specific guidance for particular laboratory disciplines or technology platforms.

This document does not apply to industrial IVD medical device production or research and academic laboratories developing tests for non-IVD purposes. However, the concepts and principles outlined in this document may still be useful for such settings.