Medical Devices (includes In Vitro Diagnostics)
MDIC’s Clinical Dx program includes gathered information from FDA, Industry, and Payers to create a framework to help diagnostic test manufacturers streamline the path to bring diagnostic technology to clinical practice. As IVD test developers are deciding how to develop their evidence, the new framework will help them to simultaneously develop evidence for both analytical and clinical validity, along with clinical utility. IVD test developers will save time and resources if they develop their evidence simultaneously instead of sequentially. Come learn about this MDIC program!