A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

In addition to the cost, the excessive overuse of laboratory testing causes patient discomfort and can lead to hospital-acquired anemia, which results in additional testing, prolonged hospitalizations ...

The FDA finalized a rule April 29 to treat laboratory-developed tests as medical devices, putting them in the purview of federal oversight. Under the new rules, the FDA will phase in oversight of ...

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.

Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...

This study shows automatic, practical, simple, and effective strategies designed in the laboratory, in consensus with requesting clinicians, to improve laboratory test appropriateness. Objectives: The ...