Featured Resources

AdvaMed’s feedback on the CEIVD draft outlines targeted recommendations to improve clarity in clinical evidence expectations for IVD devices, including more precise terminology, alignment with global frameworks, and clearer distinctions between real-world data and evidence.

This report focuses on coverage for devices and issues related to procedural delays, the lack of transparency in Medicare’s National Coverage Determination process, the use of Coverage with Evidence Development, harmonizing with the FDA, and ensuring patient safety.

This document is intended to outline some of the potential considerations and possible approaches to help research sponsors improve inclusion of under-represented groups in clinical research.