As of September 2024, there remains enormous uncertainty about the FDA’s final rule on laboratory-developed tests (LDTs). Will it hold up in court? Which tests are subject to which requirements? How can laboratories best prepare? In this interview, Dr. Jonathan Genzen, ARUP’s chief medical officer and senior director of governmental affairs, responds to questions sent in by members of the laboratory community. 

Related Information: 

• ARUP Resources on the FDA’s Final Rule on Laboratory-Developed Tests (https://www.aruplab.com/fda-ldt-final-rule)
• ARUP Webinar--The FDA’s Final Rule on LDTs: What You Need To Know (https://youtu.be/nGQ3sRfWkBg)
• ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests (https://www.aruplab.com/news/05-30-2024/arup-files-declaration-support-lawsuit-challenging-fdas-rule) 
• FDA email address for questions on the final rule: ([email protected])