January 21, 2021

MDIC is seeking public comment on its framework External Evidence Methods: Statistical Methods for Leveraging External Data in Regulatory Decision-Making

This framework intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. It catalogs different sources of external data and traditional and novel statistical methods 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 of medical devices, or the modification of their indications.

View the framework here.

The public comment period is open from Thursday, January 21 – Monday, February 22, 2021 at 5 pm ET.

An informational webinar will be held on February 10, 2021.