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 decision March 31. 
 
The AHA previously expressed concerns about the rule when it was proposed and urged the FDA not to apply it to hospital and health system lab-developed tests.