FDA declines to appeal court order that stopped LDT final rule

FDA declines to appeal court order that stopped LDT final rule

“The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen analysts wrote.

FDA will not appeal court decision striking down lab-developed test rule: 5 notes – RamaOnHealthcare

The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The

FDA doesn’t appeal court ruling invalidating lab-developed tests rule, effectively eliminating it

A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its final rule to regulate laboratory-developed tests as medical devices, effectively eliminating it. The rule, issued last year, would have phased out its general enforcement discretion approach for most lab-developed tests over four years. The U.S. District Court for the Eastern District of Texas struck down the rule in a de…

America's Blood Centers Applauds Administration’s Decision Not to Appeal Court Ruling on FDA's LDT Final Rule

Decision is a victory for patient care and laboratory innovation Washington, DC – America’s Blood Centers (ABC), the national organization of community-based, independent blood centers that supply 60 percent of the nation’s blood supply, released the below statement, following the Trump Administration’s decision not to appeal the March 31st federal court ruling that invalidated the Food and Drug Administration’s (FDA) final rule regulating labor…