“FDA’s role in regulating medical devices: premarket and scientific research programs”
Dr. Yuan Fang
Regulatory Scientist, U.S. Food and Drug Administration (FDA)
Abstract: The Center for Devices and Radiological Health (CDRH) is a branch of the U.S. Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices in the U.S., as well as the postmarket and compliance aspects by overseeing the manufacturing, effectiveness and safety of these devices. The mission of CDRH is to protect and promote the public health. In support of this mission, a broad strategic scientific regulatory research program is in place.
This presentation will give an overview of the premarket approval process of medical devices, in particular for radiation-emitting devices such as diagnostic x-ray systems. The presentation will also include a summary of a research project conducted in CDRH on the use of Monte Carlo methods for modeling image quality in semiconductor x-ray detectors.
Speaker Bio: Dr. Yuan Fang received his BASc and PhD (Electrical Engineering) from the University of Waterloo. He is the recipient of numerous awards including the prestigious Alexander Graham Bell Canada Graduate Scholarship (NSERC CGS D) and Carl A. Pollock fellowship. Dr. Fang currently works at the U.S. Food and Drug Administration (FDA) and serves as a lead reviewer for premarket approval of medical devices, specializing in diagnostic x-ray systems. He has been with the agency since 2009, and published over 20 scientific journal papers and refereed conference proceedings, and a book chapter on the use of Monte Carlo methods for modeling image quality in semiconductor x-ray detectors. Dr. Fang is a member of the IEEE, SPIE, PEO and AAPM, and currently a liaison for the American Association of Physicists in Medicine TG-150 for acceptance testing and QC of digital radiography units. He is an advocate for new technologies with two issued US patents, and serves as a reviewer for journals such IEEE Electron Device Letter, Sensors and Transactions on Medical Imaging.
If you are interested in meeting with Dr. Fang, please email Krystina Bednarowski
Pay parking available in lots B or N (map)
Event is FREE and there will be coffee/cookies available
Event sponsored by IEEE Electron Devices Society (IEEE EDS) and the Centre for Bioengineering and Biotechnology (CBB)
200 University Avenue West
Waterloo, ON N2L 3G1