On March 5, 2020, The Verifying Accurate, Leading-edge In Vitro Clinical Test Development (VALID) Act was introduced in the U.S. House and U.S. Senate. While borrowing many concepts from the Food, Drug, and Cosmetic Act, the VALID Act would establish a new regulatory framework under the FDCA for the review and oversight of all in vitro diagnostic tests terming such in vitro clinical tests. AdvaMedDx, with the guidance of the AdvaMedDx member Dx Task Force, has developed the VALID Assessment Framework as a tool to analyze the legislation.