The bipartisan legislation, introduced this week in the House and Senate, seeks to prevent more cuts to Medicare ...
This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...
The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices. Under the rule, the FDA would have phased in oversight of laboratory-developed tests ...
A third-party provider will review test requests, order tests, deliver results through the Whoop app, and provide phone ...
GlobalData on MSN
FDA scraps ‘Final Rule’ classifying LDTs as medical devices
The FDA’s move to nix its ‘Final Rule’ comes in response to the legislation’s strike down in a Texas court in March 2025.
The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules ...
Certification critical to broad U.S. market release of the CNSide CSF Assay PlatformCNSide now meets key federal and state regulatory ...
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