Preparing for Changes in Laboratory Regulations

The U.S. Food and Drug Administration (FDA) regulation of laboratory-developed tests (LDT) and implementation of the Protecting Access to Medicare Act (PAMA) are both topics of high interest in the laboratory industry. In this episode of Mayo Clinic Laboratories’ “Leveraging the Laboratory” podcast, host Jane Hermansen, outreach manager at Mayo Clinic Laboratories, speaks with Shannon Bennett, director of Quality and Regulatory Affairs for the Department of Laboratory Medicine and Pathology at Mayo Clinic, about these two topics, giving listeners: Background to help them make informed decisions. Actionable steps to take today to prepare for implementation. Ideas for advocating for your laboratory. Sources for learning more and staying informed.