Trends | Laboratory-Developed Tests | clinicallab

Laboratory-Developed Tests

6-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

Photo of a red wood block that reads, Regulations, referring to the new regulation of lab-developed tests by the FDA.

May 23, 2024|6 min read

A Timeline of Laboratory-Developed Test Regulation in the US

A Timeline of Laboratory-Developed Test Regulation in the US

Sign outside FDA headquarters

May 14, 2024|3 min read

ADLM President: 'LDTs Should Remain under CLIA'

ADLM President: 'LDTs Should Remain under CLIA'

Photo of several laboratory blood sample tubes in a rack on a clinical laboratory bench.

May 14, 2024|2 min read

The FDA's Final LDTs Rule Is Out—Now What?

The FDA's Final LDTs Rule Is Out—Now What?

Banner of the the may 30, 2024, joint Today's Clinical Lab and G2 Intelligence webinar on the FDA's new LDT rule.

May 03, 2024|2 min read

What You Need to Know about the FDA's New LDT Regulations

What You Need to Know about the FDA's New LDT Regulations

Photo of the sign in front of the U.S. FDA headquarters in Washington, DC.

Apr 30, 2024|5 min read

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

Photo of laboratory-developed tests sample tubes in a clinical laboratory.

Nov 28, 2023|3 min read

U.S. FDA Proposed Rule on Laboratory-Developed Tests

U.S. FDA Proposed Rule on Laboratory-Developed Tests