The U.S. Food and Drug Administration (FDA) late last week officially issued its draft framework for how the agency plans to regulate laboratory-developed tests (LDTs). The 41-page framework, which … [Read more...]
Labs Urged to Coordinate With CDC on Ebola Testing
The Centers for Medicare and Medicaid Services (CMS) is urging clinical laboratories to coordinate with the Centers for Disease Control and Prevention (CDC) and state public health laboratories before … [Read more...]
FDA to Hold Workshop on LDTs
The Food and Drug Administration (FDA) will hold a two-day public workshop in early January to discuss its framework for regulatory oversight of lab-developed tests (LDTs). The workshop will be Jan. … [Read more...]
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...]
EBOLA Continues to Warrant Attention From Labs
While public interest and mainstream media coverage of Ebola may appear to be waning, the outbreak has not ended and the latest CDC reports indicate the total cases exceeds 20,000 and is still rising. … [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...]
