The goal of this MDIC Clinical Dx initiative is to establish a foundation under which the use of surrogate samples can support product development with an initial focus on studies to support product submissions. One of the deliverables is to deliver an analysis of the use of surrogate samples to clearly understand and document under what circumstances such samples might be needed to verify or validate the safety and effectiveness of an IVD medical device. This included a survey of individuals that use or develop surrogate samples and analysis of publicly available IVD submission data via FDA’s Premarket Notification and Premarket Approval databases (e.g., 510(k) summaries, SSEs).