TAG:
clia
Language in Draft House Bill Directs FDA to Suspend LDT Rule
THERE IS AN INTERESTING NEW DEVELOPMENT associated with the regulation of laboratory deve…
Several Times, Feds Tried to ‘Redirect’ Lab Activities
CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…
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…
Labs Should Prepare for Arrival of ‘Perfect Storm’
CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…
CMS Issues AI Guidance for Medicare Advantage
CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…
February 26, 2024, Intelligence: Late-Breaking Lab News
Following an investment of $1.75 million, officials at University of Maine at Augusta (UMA) opened a new lab facility this month that allows it to double the number of medical laboratory technicians it can train, from eight to 10 to as many as 20. In its coverage of the new training …
FDA & CMS Issue Letter, Agree on LDT Oversight
CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…
CLIA Lab Directors Must Watch Delegated Duties
CEO SUMMARY: Laboratory accredito…
Two Forces Push for More FDA Oversight of LDTs
CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administrati…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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