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Captain Brian Lewis, M.D.

Chief Medical Officer

Captain (CAPT) Lewis is a Senior Regulatory Review Officer at the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health in cardiac pacemakers and implantable cardioverter defibrillators. He has served in this position since joining the Commissioned Corps of the U.S. Public Health Service (Corps) in 2003, following nine years of arrhythmia cardiology private practice in Washington, D.C.

CAPT Lewis provides lead clinical regulatory FDA guidance to industry to facilitate clinical trials collecting the right data and answering the right questions to provide a meaningful picture of pacemaker, defibrillator and lead safety and effectiveness to support market approval. He is a leading FDA voice in the development of clear and truthful device labeling. CAPT Lewis has led FDA’s best practices to address pacemaker, defibrillator and lead failures, including detection and care of recalled devices and best practices to communicate this complex information to physicians and patients.

He is board certified in cardiology and continues to see arrhythmia patients and perform surgery weekly at the Washington, D.C.. Veterans Affairs Medical Center, where he often brings FDA colleagues to observe his work. He has been an active member of Heart Rhythm Society for over 25 years.

CAPT Lewis served a three-year term as Physician Member of the Commissioned Officers Board of Directors, including Chairing the Awards Committee. He has served on the Benefits Subcommittee of the Physicians Professional Advisory Committee (PPAC) since 2015. He is Director of the Medical Services Branch of PHS-1 Rapid Deployment Force and has been an active member of the team since deploying with the team in 2005 to provide medical care to people affected by Hurricanes Katrina and Rita. He most recently deployed with the team to Florida for Hurricanes Irma and Maria. CAPT Lewis conducts and plays guitar for the USPHS Music Ensemble and sings the National Anthem for many FDA promotion and awards ceremonies.

He received his Bachelor of Arts from Johns Hopkins University in 1982 and a Doctor of Medicine degree from Northwestern University Medical School in 1987, completed Internal Medicine Residency at Johns Hopkins Bayview Medical Center in 1990 and completed fellowships in Cardiology and Cardiac Electrophysiology at St. Louis University Health Sciences Center including training in bedside bioethics consultation in 1994. CAPT Lewis Chaired the Bioethics Consultation Service at Washington Hospital Center in Washington, D.C. from 1997-2000.

CAPT Lewis and his wife, Katherine, a journalist and author, and their children Maddie and Ava live in Potomac, MD. His oldest daughter Samantha is a research analyst and programmer in Cambridge, Massachusetts. CAPT Lewis and his wife are volunteer parent educators for Parent Encouragement Program, Kensington, MD where he has developed programs to encourage dads in their parenting goals.

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