FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
Lab Compliance Advisor
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
Labs in Court: A Focus on Individual Accountability
Recent False Claims Act settlements underscore the government’s emphasis on individual accountability in healthcare fraud matters
Keeping Your AI Tools Safe
The potential occupational safety pros and cons of artificial intelligence implementation into the clinical lab
Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule
Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
How to Prevent the Top 10 CLIA Deficiencies
A laboratory safety expert shares the most common CLIA citations from recent lab inspections, and how your lab can avoid similar problems.
ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
10 Top CLIA Deficiencies for Labs and How to Avoid Them
Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies
What the FTC’s New Noncompete Rule Means for Your Lab
The new rule, slated to go into effect September 4, will ban noncompete agreements for most workers, including those in the lab industry
Perfect Partners: Healthcare Quality and the Clinical Lab
How labs form an indispensable part of the CMS National Quality Strategy, helping to drive healthcare improvements and scientific growth.
July 2024 Labs in Court
Genetic testing related fraud was a theme in recent enforcement actions involving medical laboratories and lab testing
Becoming Proficient in Proficiency Testing
Quality expert Sten Westgard discusses the latest CLIA update: “It’s time to have performance goals built in this century”
