BME Seminar Series: Mitchell Shein
FDA Engineers' Roles in Regulatory Science and the Development of Standards
Chief of Implantable Electrophysiological Devices Branch Division of Cardiovascular Devices
The discussion will begin with an overview of the standards development process, followed by an open discussion on engineer's roles in Regulatory Science as well as the development of device standards at the Center for Devices and Radiological Health in the US Food and Drug Administration.
Mitchell Shein joined the Center for Devices and Radiological Health in August 1986, as a reviewer in the Office of
Device Evaluation's Division of Cardiovascular Devices. He is currently the Branch Chief for the Implantable Electrophysiological
Devices Branch in that Division. This branch is responsible for the premarket evaluation of cardiac pacemakers and implantable
defibrillators (ICDs); as well as, the leads used to
connect devices to the heart. In addition to his responsibilities as branch chief,
Mr. Shein is active in the development of standards for cardiac pacemakers and implantable defibrillators.
These activities include chairing both the ISO Joint Working Group on Cardiac Pacemakers and Defibrillators, and the working group developing
the vertical standard regarding the interaction of magnetic resonance (MR) imaging and pacemakers and ICD. Mr. Shein began his career in the
Federal Government in 1982 as a Patent Examiner at the U.S. Patent and Trademark Office, reviewing patent applications for devices that applied
electricity to the body therapeutically. His educational background includes a B.S. in Biomedical Engineering from Duke University and a M.S.
in Physiology from Georgetown University.