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, ...

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 ...

The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency oversees other diagnostics. At its heart, the 528-page final rule (PDF) looks ...

The Food and Drug Administration’s plan to expand oversight of laboratory-developed tests threatens to prevent or delay patient access to innovative diagnostics, industry groups warned in ...

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland (Reuters) -The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a ...

A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed ...

The Biden administration's contentious plan to increase federal regulation of diagnostic medical tests could be swiftly ...

Most laboratory developed tests are created because there is not already a Food and Drug Administration-approved test available, and they are often used to diagnose rare conditions, such as inherited ...

Stable isotope-labeled internal standards are widely used in laboratory-developed clinical mass spectrometry tests. An equal amount of these internal standards is added to all samples in a batch, ...

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same ...