TAG:
clinical laboratory improvement amendments
Why Labs Should Comply with FDA’s Final Rule on LDTs
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
Artificial Intelligence and Executive War College
By the time you read this our 29th annual Executive W…
FDA Issues Memo to Reclassify Many High Risk IVD Assays
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
Alert! Changes to CLIA Accreditation, CLIA Revisions
MEDICAL LABORATORIES HAVE LIVED WITH THE REGULATIONS FOR THE CLINICAL LABORATORY IMPROVEMENTS AMENDMENTS (CLIA) since they were first implemented in 1992. Over the past 30 years there has been no major revision or updating of CLIA regulations. Nor has there been much change in the long-standing statu…
Clinical Laboratories Face 20% Increase in CLIA Fees
CHANGES HAVE BEEN PROPOSED to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that would raise fees by 20% for clinical laboratories and amend certain testing personnel qualifications. The American Hospital Association (AHA) has obj…
Might LDT Regulation Bill Support Be Waning in Congress?
This is an excerpt of an 833-word article in the July 18, 2022 issue of THE DARK REPORT. The full article is available to members of The Dark Intelligence Group. …
Might VALID Act Support Be Waning in Congress?
CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Lea…
Halfway Through 2022, More Changes Come at Labs
APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year. For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges co…
Passage of FDA Regulation of LDTs Inches Closer in the Senate
CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …
VALID Act vs. VITAL Act: Day of Reckoning for LDTs
TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests….
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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