MDIC is seeking public comment on its Study Design Blueprint for Evaluating Analytical Performance Characteristics of Point of Care In Vitro Diagnostic Devices with Capillary Whole Blood (Fingerstick) Specimens. This document is intended to serve as a study design blueprint for using capillary whole blood (fingerstick) data for analytical validation of IVD tests. This document provides general guidance on considerations for study design. Considerations for specific devices may require modifications in order to implement these studies.
View the blueprint here.
The public comment period is open from, March 4 – April 5, 2021.
An informational webinar on the blueprint was held on Thursday, March 4, 2021.