FDA IVD Chief: MDIC Fingerstick Blueprint An Antidote To Point-Of-Care Testing Device Challenges

25 Mar 2021

• By Shawn M. Schmitt

Tim Stenzel, the US agency’s top expert on in vitro diagnostics, is optimistic that a new blueprint for designing studies for POC testing devices is the key to solving an array of challenges plaguing IVD makers. The blueprint was developed by a Medical Device Innovation Consortium working group.

The US Food and Drug Administration’s top expert on in vitro diagnostics is optimistic that a new blueprint for designing studies for point-of-care (POC) testing devices is the key to solving an array of challenges plaguing IVD makers.

The 46-page blueprint report from the Medical Device Innovation Consortium (MDIC) – “The Study Design Blueprint for Evaluating Analytical...