The US FDA’s proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing

Posted on May 26, 2024 By LabLynx Journal articles

In this "in press" journal article published in Practical Laboratory Medicine, Smith et al. of ARUP Laboratories provide the results of a survey conducted just prior to the U.S. Food and Drug Administration's (FDA's) April 29 release of their final rule on laboratory-developed tests (LDTs). Polling a select group of its clinical laboratory customers, the authors sought to discover clinical laboratorians' opinions about the then proposed changes to regulate LDTs as medical devices. The survey was conducted in part due to a set of perceived FDA shortcomings that would make it "difficult for the FDA to conduct an accurate quantitative analysis of public opinion in a key sector directly impacted by its proposed rule." The authors describe the structure of their survey and its associated analytical methods before discussing the results. They then provides a full discussion with a brief conclusion: "The majority of clinical laboratorians surveyed do not support the FDA’s proposed rule on LDTs and report having insufficient resources to comply with the rule if it is enacted," and that the FDA had more work to do "to better understand the negative impacts of the proposed rule."