TAG:
fda regulation of ldts
New Twist: HHS Exerts Authority Over FDA on LDTs
CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…
FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says
This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…
HHS ‘Stands Down’ FDA on Its Oversight of LDTs
CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…
TOP 10 LAB STORIES OF 2017
1. CMS Sticks by Decision to Deeply Cut Medicare Part B Lab Test Fees SHORT OF A MIRACLE, the clinical laboratory industry is less than three weeks from the single most financially-disruptive event of the past 30 years. On Jan. 1, the federal Centers for Medicare and Medicaid Service…
Congress Seems Ready to Tackle LDT Regulation
RECENT DEVELOPMENTS SIGNAL THAT THE FIGHT over FDA regulation of laboratory-developed tests (LDTs) is about to intensify. Last month, two Congressional representatives announced a new bill about LDTs that they said was a “discussion draft.” The bill is titled the “Diagnostic Accuracy and Innova…
NY Times Asks: ‘Is Lab Testing the Wild West?’
HOW MANY OF YOU SAW THE NEWS STORY PUBLISHED LAST MONTH by The Wall Street Journal with the headline, “Is Lab Testing the ‘Wild West’ of Medicine?” It is the latest in a series of news stories about issues and questions involving the accuracy and quality of clinical laboratory tests …
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
LabCorp, Quest Diagnostics Report Improved Q-3 Revenue
THIRD QUARTER EARNINGS at each of the nation’s two biggest public lab companies showed improved growth in revenue and specimen volume, as compared to recent years. Laboratory Corporation of America was first to release its financial report for the quarter ending September 30, 2014…
September 02, 2014 “Intelligence: Late- Breaking News”
There will be one less vendor of laboratory information systems (LIS) when a major acquisition is completed. Last month, Siemens AG announced that it would sell Siemens Health Services to Cerner Corp. for a price of $1.3 billion. Analysts believe tha…
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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