Regulating Laboratory Tests: What Framework Would Best Support Safety and Validity?
本文探讨了如何通过监管改革平衡实验室检测的全面审查与灵活性，以保护患者免受错误检测结果的影响，并分析了VALID法案未通过后FDA的应对策略。
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.