Program on Regulation, Therapeutics, and Law, Brigham and Women's Hospital and Harvard Medical School.
Milbank Q. 2024 Sep;102(3):558-576. doi: 10.1111/1468-0009.12701. Epub 2024 May 13.
Policy Points With increasing public attention to cases of inaccurate and misleading laboratory-developed tests, there have been calls for regulatory reform. To protect patients from faulty laboratory tests, we need a framework that balances comprehensive test review with laboratory flexibility. The Verifying Accurate Leading-edge IVCT [In Vitro Clinical Test] Development (VALID) Act would have helped ensure laboratory test safety and validity through a much-needed expansion of Food and Drug Administration (FDA) oversight. However, Congress did not pass the VALID Act in 2022, forcing the FDA to start the regulatory reform process on its own.
随着公众对不准确和误导性的实验室研发检测结果的关注度不断提高，人们呼吁进行监管改革。为了保护患者免受错误的实验室检测结果的影响，我们需要建立一个框架，在全面审查检测的同时兼顾实验室的灵活性。《验证准确前沿体外临床检测（VALID）法案》本可以通过扩大食品和药物管理局（FDA）的监管来帮助确保实验室检测的安全性和有效性，但该法案并未在 2022 年获得通过，这迫使 FDA 自行启动监管改革进程。
