Melissa Burns currently serves as the Acting Associate Director for Regulations and Guidance in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE). In this role, she is responsible for review and development of guidance documents, regulations, and office policies and procedures related to premarket review. Prior to her Associate Director detail, Ms. Burns was a Regulatory Advisor for three years in ODE. Ms. Burns also spent four years as a Compliance Officer in the CDRH Office of Compliance (OC) and completed a detail as a Quality System Specialist in OC. Before starting her career at the FDA, Ms. Burns worked for several years in the private sector including positions with a medical device manufacturer, a large acute-care hospital, a healthcare architecture firm, and a consulting firm. Ms. Burns holds a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.
Events Melissa Burns (invited) will be attending:
Combination Products Registration