Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, … [Read more...]

Labs In Court

Arizona Lab’s 20-Year Quest to Regain CLIA Certification Comes Up Empty

Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, … [Read more...]

Emerging Tests

Inside the FDA’s Four-Armed COVID-19 Test Response Strategy

What started as the traditional Emergency Use Authorization (EUA) response deployed by the FDA for previous infectious illness outbreaks has rapidly evolved into something altogether different and … [Read more...]

FDA Watch

FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices

On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA … [Read more...]

Coronavirus

Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing

On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US … [Read more...]

CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing

On Feb. 6, CMS issued guidance to labs and other providers on how to use the newly approved Centers for Disease Control and Prevention (CDC) test for coronavirus. Here are the key takeaways. The … [Read more...]

Labs In Court

Lab Gets Chance to Prove Fraud Claims against Software Vendor at Trial

Case: After being hit with a slew of CLIA penalties, a toxicology lab hired a software and IT services firm to help get its information systems back into compliance. But while progressing toward … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results

On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to market. Under the "Safety and Performance Based Pathway" (new Pathway), new product … [Read more...]

CLIA

After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules

When the CLIA (the Clinical Laboratory Improvement Amendments of 1988) proficiency testing (PT) regulations were first implemented in 1992, George H.W. Bush was President, gas cost about $1.05 per … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]


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