Many lab owners and executives are surprised to learn just how many federal agencies have oversight and regulatory authority over their laboratories. All lab owners and executives should be familiar with the U.S. Food and Drug Administration's (FDA) role in regulating laboratories in the United States, and most will be well aware of the U.S. Centers for Medicare and Medicaid Services' (CMS) role in ensuring compliance. But many owners and executives are surprised to learn that the Federal Bureau of Investigation (FBI), U.S. Department of Justice (DOJ), U.S. Department of Health and Human Services Office of Inspector General (OIG), and other federal authorities could be scrutinizing their business practices as well.