Elias Mallis , BS

Regulatory Affairs
Rockville, MD

Elias Mallis has been at the U.S. Food and Drug Administration's Office of Device Evaluation for 17 years. He graduated from University of Maryland at College Park with a Bachelors of Science in Electrical Engineering. Since his arrival at FDA, Mr. Mallis spent over 7 years as a Senior Scientific Reviewer in the Gastroenterology and Renal Devices Branch where he regulated fields including hemodialysis, extracorporeal therapeutics, gastroenterology, endometrial ablation, and liver-assist combination products. During this time, he authored several FDA guidance documents, served as a subject matter expert in design controls and directed manufacturing inspections, and participated in standards efforts. For the next 9 years, Mr. Mallis primarily served as the Branch Chief of the Cardiac Electrophysiology and Monitoring Branch, where he supervised product areas in the field of percutaneous and surgical cardiac ablation to treat arrhythmias, implanted cardiac hemodynamic monitors, non-invasive and invasive cardiac monitors, and vulnerable plaque diagnostics. Additionally, Mr. Mallis has served as Acting Deputy Director for the Division of Cardiovascular Devices and the Division of General, Restorative, Neurological Devices where the product area of responsibility including pacemakers, defibrillators, pacing leads, plastic and reconstructive implants, and general surgery technologies. For each of these positions, Mr. Mallis's role is to advice developers of medical device manufacturers in the design of clinical studies, performance testing requirements and marketing applications to support the safety and effectiveness of the new medical device. In his current role as ODE Policy Analyst, Mr. Mallis advises the ODE Director on contemporary policy initiatives involving the various device regulatory programs, in addition to working with the ODE Review Divisions in the formulation of new regulations and guidance documents.