FDA’s Crackdown on Lab-Developed Tests: Unintended Consequences for Clinical and Regulatory Professionals
In August 2020, the U.S. Food and Drug Administration (FDA) significant regulatory changes regarding laboratory developed tests (LDTs). These changes, while intended to enhance patient safety by requiring more stringent oversight, have sparked considerable debate and concern across the clinical and regulatory fields. Here, we dissect the potential negative impacts these new regulations may have […]