Lab Sector Goes to Big Legal Guns in Grapple With FDA Over Test Regulation

The American Clinical Laboratory Association (ACLA) has officially loaded up its legal howitzers in a likely path toward litigation over the U.S. Food and Drug Administration’s (FDA’s) intent to … [Read more...]

CMS Releases New CLIA-Waived Tests, Billing Codes

CMS notified contractors of new CLIA-waived tests effective January 1, 2015. There are 25 newly waived complexity tests, the latest approved by the FDA. The tests, listed in the table below, all … [Read more...]

ACLA Issues White Paper Arguing Against FDA Regulation of LDT

As NIR reported in November, the American Clinical Laboratory Association (ACLA) has hired some renowned legal advisors to respond to the FDA's proposed regulation of laboratory developed tests (LDTs) … [Read more...]