New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...

Lawmakers have told the Food and Drug Administration to suspend efforts to implement its final rule on laboratory developed tests (LDTs). The House Appropriations Committee made the request Wednesday ...

The American Hospital Association is urging the FDA not to move forward with a proposed rule to treat laboratory-developed tests as medical devices, saying the move would disrupt innovation and ...

A federal district court has struck a blow for medical innovation and patient empowerment by overruling the Food and Drug Administration's (FDA) misbegotten effort to regulate laboratory-developed ...

April 29 (Reuters) - The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a new rule that gives it more oversight of diagnostic tests developed by ...

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, ...