"FDA's Proposed Rule Enhances Safety and Effectiveness of Lab Developed Tests"

The U.S. Food and Drug Administration (FDA) has proposed a rule to ensure the safety and effectiveness of laboratory developed tests (LDTs), which are used in healthcare decisions. LDTs are in vitro diagnostic products used to measure substances in the body and provide information about a patient's health. The FDA is concerned that some LDTs may not provide accurate results, leading to unnecessary or delayed treatment and incorrect diagnoses. The proposed rule aims to provide greater oversight of LDTs and phase out the FDA's general enforcement discretion approach. The FDA believes this will protect public health and encourage responsible innovation in test development.