Abstract
In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon (Republican-Indiana) and Diana DeGette, (Democrat-Colorado). The VALID Act attempts to create a new framework for the oversight and regulations of both laboratory-developed testing procedures (commonly known as laboratory-developed tests) and In vitro diagnostic tests by the U.S. Food and Drug Administration. The potential impact of this new law if passed may be significant for clinical laboratories in terms of diagnostic test development and implementation. In this report, we review the background and key information that every clinical virologist should know about the VALID Act.