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
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
Possible Job Description for a Diagnostic Health Consultant
The role at this point is theoretical, but our editors asked AI for help in drafting what the position might entail
Diagnostic Health Consultant: A New Role Proposed for the Clinical Laboratory
While still in the early stages, Clinical Lab 2.0’s pitch for this new position fits with the need to better use lab data
No Signs of the DOJ Letting Off the Pedal with Medicare Fraud Investigations
However, a new memo instructs federal prosecutors to ‘avoid overreach’ when parties cooperate with authorities
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
Dx Deals: Quest Diagnostics M&A Centers on Precision-Focused Approach
Recent inroads into testing of water for dialysis equipment illustrates Quest’s expanded scope with deals
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
