Mayo Clinic, Jacksonville, FL, U.S.A.
RBM Consulting, LLC, U.S.A.
J Clin Virol. 2021 Aug;141:104875. doi: 10.1016/j.jcv.2021.104875. Epub 2021 Jun 1.
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.
2018 年，众议员拉里·布申（共和党-印第安纳州）和黛安娜·德盖特（民主党-科罗拉多州）提出了一项名为《验证准确、领先的体外诊断检测发展法案》（VALID 法案）的两党联合立法草案。VALID 法案试图为美国食品和药物管理局对实验室开发的检测程序（通常称为实验室开发的检测）和体外诊断检测的监督和监管建立一个新的框架。如果该新法获得通过，可能会对临床实验室的诊断检测开发和实施产生重大影响。在本报告中，我们回顾了每一位临床病毒学家都应该了解的 VALID 法案的背景和关键信息。
