In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency ...
The onset of COVID-19 proved to be a real-time stress test of America’s clinical testing system. The experience exposed several flaws in the system that policymakers should address, specifically, ...
Medical Device Network 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.
Platinum-Free Systemic Therapy in First-Line Metastatic Urothelial Carcinoma: Mirage or Oasis in the Platinum Desert? Cancer predictive or diagnostic assays, offered as Laboratory-Developed Tests ...
The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules ...
After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.
A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...
A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean ...
Certification critical to broad U.S. market release of the CNSide CSF Assay Platform CNSide now meets key federal and state ...
Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...
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