MDICx: External Evidence Methods Framework & Survey Discussion
Wednesday, June 10, 2020, 3:30 pm ET
The Medical Device Innovation Consortium (MDIC) is developing an External Evidence Methods (EEM) framework in collaboration with experts from medical device and diagnostics manufacturers as well as FDA. This document will focus on categorizing and cataloging existing statistical methods for the use of external data (including RWD, Historical data and, Modeling & Simulation) in regulatory decision-making for medical devices, thereby helping to establish a more streamlined pathway for the use of external data in regulatory submissions.
In order to gather more insights about the utilization of external data as well as identifying the gaps, we are seeking public input through an online survey. In addition, we will host a webinar to provide an overview of MDIC’s EEM activities, and to provide additional insights on the survey.
• Ram Tiwari, Director, Division of Biostatistics, Office of Clinical Evidence & Analysis | CDRH, FDA
• Ted Lystig, Senior Director, Corporate Biostatistics | Medtronic
• Vandana Bhatia, Assistant Director, Division of Biostatistics, Office of Clinical Evidence and Analysis | CDRH, FDA