External Evidence Methods Framework Webinar

February 10, 2021, 3-4 pm ET

The Medical Device Innovation Consortium External Evidence Methods (MDIC EEM) Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. It catalogs different sources of external data and some of the traditional and novel statistical methods (Frequentist and Bayesian) applicable to the design and analysis of a clinical study in which external data play a role. It also provides references to actual past studies leveraging external data in which some of these statistical methods were successfully applied to support the approval/clearance of medical devices, or the modification of their indications.

Key topics include:

  • Cataloging different sources of external data
  • Cataloging statistical methods that can be considered to leverage external data
  • Considering uses of external data, when appropriate, for premarket regulatory decision-making for medical devices
  • Providing examples to illustrate the application of various statistical methods where external data have been leveraged
  • The process for providing comments during the public comment period


  • Theodore Lystig, PhD, Medtronic
  • Vandana Bhatia, PhD, FDA | CDRH
  • Daniel Canos, PhD, MPH, FDA | CDRH
  • Lilly Q. Yue, PhD, FDA | CDRH
  • Jithesh Veetil, PhD, Program Director, Data Science and Technology, MDIC

The public comment period will be open until February 22, 2021, 5 pm ET. View the webinar recording below.