MDICx: Fingerstick Blueprint Public Comment Q&A
Thursday, March 4, 2021 | 1-2 pm ET
Fingerstick point of care technology is rapidly advancing. Analytical study designs, specifically reproducibility and method comparison in the intended use population are required to assess the performance of the system consistently by different manufacturers. However, validation of assay performance for fingerstick testing has many unique issues. The Medical Device Innovation Consortium convened subject matter experts from government and industry to create a study design for analytical performance characteristics evaluation of point-of-care devices with capillary whole blood specimens, also known as fingerstick capillary blood draws.
The Medical Device Innovation Consortium’s IVD Fingerstick Blueprint working group, comprised of IVD industry and FDA representatives, have drafted for public comment a Fingerstick Blueprint. An informational webinar on the blueprint and how to submit public comment will be held on Thursday, March 4, 2021.
• Timothy Stenzel, MD, PhD, Director of Office of In Vitro Diagnostics and Radiological Health | OHT7 | CDRH | FDA
• Shridhara Alva, PhD, Senior Director, Clinical Affairs | Abbott Diabetes Care
• Corinne Fantz, PhD, Director, Medical and Scientific Affairs-POC | Roche Diagnostics Corporation
• Rex Astles, PhD, Acting Lead, Data Science Team | Center for Disease Control and Prevention
This Blueprint draft will be open for public comment from Thursday, March 4 through Monday, April 5, 2021.