Partner Sites
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.
Read Series
A tray of lab samples
Published

Articles in this Series

Image of the US White House. Clinical labs are wondering how incoming President Donald Trump might influence LDT changes.
|3 min read
Photo of a red wood block that reads, Regulations, referring to the new regulation of lab-developed tests by the FDA.
Updated |5+ min read
Sign outside FDA headquarters
|3 min read
Photo of several laboratory blood sample tubes in a rack on a clinical laboratory bench.
|2 min read
Banner of the the may 30, 2024, joint Today's Clinical Lab and G2 Intelligence webinar on the FDA's new LDT rule.
Updated |2 min read
Photo of the sign in front of the U.S. FDA headquarters in Washington, DC.
|5 min read
Photo of laboratory-developed tests sample tubes in a clinical laboratory.
|3 min read
Read Series