FDA, Lab Chiefs Raise Concerns About CLIA As Others Push To Build On Current Law

As one laboratory association urges senators to modernize lab-test regulatory oversight by building on the current Clinical Laboratory Improvement Amendments program as an alternative to FDA oversight, several state health departments and lab administrators told Inside Health Policy they see possible hurdles to updating the CLIA framework and voiced concerns about lack of regulation under the current policy, with an FDA official also pointing to shortcomings with the law. For a number of years, FDA has exercised enforcement discretion with...