Medical laboratory scientists collect samples and perform lab tests, calibrate and maintain equipment, and perform statistical analysis. Their work is crucial for clinicians to diagnose diseases.

Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs). In a major shift, ...

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products" to specify that such definition "[includes] when the ...

Forbes contributors publish independent expert analyses and insights. Rodney Rohde,PhD is a Professor and Chair for the Clinical Laboratory Science (CLS) Program in the College of Health Professions ...