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, ...

Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing ...

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 ...

Sept 18 (Reuters) - The U.S. Food and Drug Administration will rescind a rule that tightened regulations for clinical laboratories and gave the agency more oversight of diagnostic tests developed by ...

Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland (Reuters) -The U.S. Food and Drug Administration ...

“LDTs are being used more widely than ever before—for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s,” said FDA Commissioner ...

The Food and Drug Administration has finalized a divisive plan to regulate laboratory medical tests — including some used to diagnose cancer and Alzheimer’s disease — over concerns about reliability ...

A judge said Congress created a separate certification framework for laboratory test services, known as CLIA, and that laboratory-developed tests should fall under that category. (Getty Images) A ...

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg recently announced that her agency would soon end a long-standing policy of enforcement discretion toward a classification of ...

This article originally appeared on ProPublica. The Big Story newsletter to receive stories like this one in your inbox. The Food and Drug Administration issued a rule on Monday that brings new ...