A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
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Articles and Reports
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
Interconnected Clinical Lab Devices Can Increase Operational Capabilities
However, integrated technologies must take into account data protection concerns
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
Check Out These 5 Tips to Better Retain Clinical Lab Staff
Options include establishing career trajectory plans and offering smooth onboarding for incoming laboratory scientists
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Routine Mass Spectrometry in Clinical Labs: A Competitive Advantage?
How a new automated system bringing MS to routine lab testing could help set laboratories apart from their competitors
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Updates to CLIA Personnel Requirements May Lengthen Hiring Times
Changes ‘have had a significant impact on the recruitment process for laboratory directors and technical supervisors,’ recruiter says
