Elias Mallis , BS

Director
Regulatory Affairs
Food and Drug Administration
Rockville, MD

Elias Mallis is the Director of the Division of Small Manufacturers, International, and Consumer Assistance in CDRH's Office of Communication and Education, a position he has held since August 2011. In this role, Mr. Mallis leads a division whose mission is to educate and inform the industry, consumer, and government stakeholders of medical devices. Mr. Mallis began his FDA and career in 1994 and devoted the next 16 years in the Office of Device Evaluation, involved with the regulatory review and policy development of a diverse range of medical device programs, such as 510(k)s, IDEs, PMAs and HDEs. In his first position, Mr. Mallis as an Electrical Engineer in the Gastroenterology and Renal Devices Branch, where he was responsible for the review of medical products in the fields of hemodialysis, extracorporeal therapeutics, gastric motility and incontinence, and endometrial ablation. After 8 years in this role, Mr. Mallis served another 8 years as the Branch Chief of the Cardiac Electrophysiology and Monitoring Branch, where he was responsible for cardiovascular disciplines such as cardiac ablation for treatment of atrial fibrillation and implanted heart failure diagnostics. Mr. Mallis also served in the ODE Front Office as a Policy Analyst where he contributed to various policy efforts such as the Updated 510(k) Program Guidance and Pivotal Clinical Studies Guidance.