This session will describe the current state of clinical evidence planning for medical devices with respect to regulatory submissions (with emphasis on the expectations of the U.S. Food and Drug Administration and the European Union Commission) and broader business needs (e.g., reimbursement, support of claims). A description with specific examples of implementation of an integrated clinical evidence strategy and deliverables within medical device research and development (R&D) will be shared. Benefits and challenges encountered with clinical evidence planning and regulatory submissions for medical devices used in oncology settings will also be shared. Specific action points for organizations looking to build an integrated evidence strategy will be described and discussed.

CEU: 1.00 ACRP

Speaker:

• Lisa Colton, Clinical Regulatory Lead, BSI

• Regina Fulkerson, PhD, Director, Clinical Evidence Planning & Evaluations, Varian Medical Systems

• Jamie Marigold, PhD, Clinical Evidence Planning & Evaluations Manager, Varian Medical Systems

• Eric Sugalski, Founder & CTO, Archimedic