CAPT. Melissa B. Burns

Senior Program Manager, Office of Combination Products, FDA/CDER

CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Melissa has significant experience in current good manufacturing practices (CGMPs) for combination products and has been heavily involved in FDA’s ongoing efforts to improve the intercenter consult process and combination product premarket review processes and procedures as well as development of guidance on postmarket safety reporting for combination products. Prior to joining OCP, Melissa was a Regulatory Advisor in FDA’s Center for Devices and Radiological Health (CDRH)/Office of Device Evaluation (ODE) where she coordinated guidance and regulation development and internal policies related to the premarket review of medical devices. Prior to CDRH/ODE, she was a Compliance Reviewer in the CDRH Office of Compliance, where she performed reviews of Quality System, manufacturing and product recall information and coordinated regulatory actions. Melissa 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. CAPT Burns received 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.