New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
The proposal seeks to move any future LDT authority away from the FDA
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
Laboratories must register for email-only communications and submit all CLIA fees electronically
CMS tweaked its CE, documentation, and on-site visit requirements for directors
Third-party verification of lab personnel experience is now a CLIA requirement
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Learn how CLIA could be used as a blueprint to regulate emerging technologies in an effective and dynamic way
Washington State’s Department of Health details how its medical testing site program meets federal standards
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services