7-Part Series
Laboratory-Developed Tests
On April 29, the FDA announced a final rule amending the FDA’s regulations explicitly stating that IVDs, including lab-developed tests or LDTs, are devices under the Federal Food, Drug, and Cosmetic Act. Here's everything you need to know to navigate the new LDTs regulations.
Articles in this Series
Will President-Elect Donald Trump Change the FDA’s LDT Final Rule?
Will President-Elect Donald Trump Change the FDA’s LDT Final Rule?
A Timeline of Laboratory-Developed Test Regulation in the US
A Timeline of Laboratory-Developed Test Regulation in the US
ADLM President: 'LDTs Should Remain under CLIA'
ADLM President: 'LDTs Should Remain under CLIA'
The FDA's Final LDTs Rule Is Out—Now What?
The FDA's Final LDTs Rule Is Out—Now What?
What You Need to Know about the FDA's New LDT Regulations
What You Need to Know about the FDA's New LDT Regulations
FDA Takes Aim at Ensuring the Safety and Effectiveness of Laboratory Developed Tests
FDA Takes Aim at Ensuring the Safety and Effectiveness of Laboratory Developed Tests
