Regulatory Strategies for Medical Device Market Clearance – the 510(k) pathway
Friday, April 14, 2017 from 9:00 AM to 5:00 PM (PDT)
San Francisco, California
London, United Kingdom
This session builds on the foundations discussed in the first session of the medical device series of UCSF-Stanford CERSI mini-courses. Upon completion of this session, students will be able to:
- describe the 510(k) submission process and the circumstances that apply for each type of submission
- explain the definition of “substantial equivalence” and how it is determined
- review the process for determining if a device change requires a new or special 510(k), or requires no 510(k)
- list the steps in generating traditional 510(k) and de novo 510(k) submissions
- utilize with FDA resources to help with producing 510(k) submissions
Basic understanding of FDA regulation of medical devices, e.g. completion of CERSI mini-course "Introduction to U.S. Device Regulation".
Mary Ann Smith, Regulatory Policy Head for Digital Medicines and Medical Devices, NOVARTIS PHARMACEUTICALS CORPORATION
Branden Reid, Ph.D., is a Global Regulatory Affairs Lead at Becton, Dickinson, and Company (BD) in the Preanalytical Systems business unit.
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UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)
Center of Excellence in Regulatory Science and Innovation is a partnership between University of California San Francisco (UCSF), Stanford University and U.S. Food and Drug Administration (FDA).