Engagement with the FDA on Premarket Submissions and Inspections by Yuan Fang

Yuan Fang, PhD MBA P.Eng RAC

Yuan currently serves as the Director of Design Quality at Hologic Inc., and serves as a member of the Board of Directors of several private medical device companies. Yuan worked at the U.S. Food and Drug Administration for 8+ years and as the acting Branch Chief and team lead, he led multidisciplinary review teams for 150+ medical device premarket submissions (including PMA, IDE, 510(k) and 513(g)) and 100+ compliance assignments (inspections, warning letter resolutions, recalls, ARO and trade complaints). Yuan received the prestigious FDA Outstanding Service Award for his contributions and expertise in Total Product Life Cycle (TPLC) management and the lead author on the FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices. Yuan received his PhD majoring in Electrical Engineering from the University of Waterloo, MBA from Ivey Business School - Western University and is a licensed Professional Engineer (P.Eng) in the province of Ontario. 

Date: Friday, August 14, 2020
Time: 2:00 pm, Eastern Daylight Time (New York, GMT-04:00)

Session number: 160 153 3100
Session password: CREATE


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