Shani Haugen, Ph.D. is the Assistant Director for the Gastroenterology and Endoscopy Devices Team at FDA's Center for Devices and Radiological Health. She holds bachelor's and doctoral degrees in Microbiology from the University of Illinois, Urbana-Champaign and the University of Wisconsin, Madison, respectively. She joined FDA in 2009 and focused on the review of gastrointestinal endoscopes. As the Assistant Director, Dr. Haugen leads a team of FDA reviewers to oversee the safety and effectiveness of a variety of gastroenterology medical devices.