CMS releases list of 12 new CLIA-waived tests
The Centers for Medicare and Medicaid Services has extended the comment period on proposed changes to proficiency testing to June 4.
On February 4, 2019 CMS released the “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance” proposed rule on.
On December 28, 2018 CMS published its CLIA User Fee Update.
The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.