The Proposed VALID Act: A Possible Next Step in FDA’s Goal of Regulating LDTsFebruary 1, 2019 Download PDF
This article discusses a Congressional draft proposal, The Verifying Accurate
Leading-Edge IVCT Development (VALID) Act of 2018, aimed at making
regulatory changes for Laboratory Developed Tests (LDTs). The authors identify
a number of important points about the draft and offer analysis and commentary on proposed changes to classification and premarket review, precertification, registration and notification and appeals. They suggest that if the draft VALID Act became law, it would have far-reaching and potentially negative consequences for physicians and their patients.