The CMTI is thrilled to announce that Mitchell Shein, M.S., F.H.R.S., the former FDA Deputy Director of the Division of Cardiovascular Devices will visit and participate in the BME 431 course (Pathways to Medical Innovation – FDA and IP considerations). Students will benefit in hearing about how to gain clearance and approval of devices through the FDA from a former Deputy Director. CMTI students will also spend time over lunch with Mr. Shein to discuss what it is like to work at the FDA.
Mr. Shein has over 30 yrs of experience at the FDA in the area of cardiovascular devices. He has also served as a Patent Examiner for the USPTO. He currently serves as a consultant for both NDA Partners, LLC and CPR Consulting, LLC.