The U.S. Food and Drug Administration (FDA) has announced a new regulatory framework for laboratory developed tests (LDTs), which are increasingly used in critical health care decisions, such as newborn screening and diagnosing diseases like cancer, heart disease, and Alzheimer's. This move comes after longstanding concerns about the safety and effectiveness of LDTs. The FDA plans to phase out its general enforcement discretion for these tests over four years, aiming to ensure that patients receive accurate and reliable results. The decision has sparked debate, with some viewing the regulations as burdensome while others believe they provide necessary oversight to protect patient health. In response, the VALID Act has been proposed to create rational oversight for these tests.